K Number

Device Name

OAK RIDGE PRODUCTS SHARP CONTAINER

Manufacturer

OAK RIDGE PRODUCTS, LLC

Date Cleared

2013-06-21

(136 days)

Product Code

MMK CLA

Regulation Number

880.5570

Intended Use

Oak Ridge Products Sharps containers are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals. The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device. The 5.4 quart is intended to be used with an appropriate mounting device. The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

Device Description

The Oak Ridge Products Sharps Containers are an injection molded polypropylene plastic designed for a single-use. The containers are puncture resistant, leak resistant on the sides and bottom, closable and stable. The products have engraved maximum fill lines on the containers and instructions for locking the container closed. Labels are white with black text and a black bio-hazard symbol printed on an orange-red background. Labels are adhered to the containers at the time of manufacture with the fill line warning matching the engraved fill line on the container. The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. Parts are nested together to reduce storage and shipping requirements. The bases are offered in natural (translucent) or colored (red). These are available in three sizes; 1) 1 quart Phlebotomy, 2) 5.4 quart for Patient room and 3) 2 gallon containers. Lids and closures are uncolored translucent material. The translucent nature of the product allows for a visual determination of content level.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K943575, K943659, K943660

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple, single-use plastic container for sharps disposal and the description focuses on its physical properties and performance in bench testing. There is no mention of any computational or analytical capabilities, let alone AI/ML.

Therapeutic

No
The device is a sharps container used for the safe disposal of hazardous sharps, not for treating or diagnosing medical conditions.

Diagnostic

Explanation: The device is a sharps container used for the safe disposal of hazardous medical waste, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device is a physical container made of injection molded polypropylene plastic, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Oak Ridge Products Sharps containers are designed for the safe disposal of hazardous sharps. Their function is to contain and isolate waste materials, not to perform any diagnostic tests on biological samples.
Intended Use: The intended use clearly states "for safe disposal of hazardous sharps". It does not mention any diagnostic purpose.
Device Description: The description focuses on the physical characteristics of the container (material, size, puncture resistance, etc.), which are relevant to its function as a waste disposal unit, not a diagnostic tool.

Therefore, based on the provided information, the Oak Ridge Products Sharps containers are not IVD devices. They are medical devices used for waste management in a healthcare setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device.

The 5.4 quart is intended to be used with an appropriate mounting device.

The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

Product codes (comma separated list FDA assigned to the subject device)

MMK

Device Description

The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. Parts are nested together to reduce storage and shipping requirements. The bases are offered in natural (translucent) or colored (red). These are available in three sizes; 1) 1 quart Phlebotomy, 2) 5.4 quart for Patient room and 3) 2 gallon containers. Lids and closures are uncolored translucent material. The translucent nature of the product allows for a visual determination of content level.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained healthcare professionals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Oak Ridge Products Sharps Containers conform to the recognized standard ASTM F2132-01(2008) for needle puncture resistance and meet or exceed the OSHA 1910.1030 recommendations for sharps containers. The performance testing demonstrates compliance with ASTM F2132-01 (reapproved 2008) and applicable portions of ISO 23907 First Edition 2012-09-01. The relevant FDA guidance document, "Guidance on the Content and Format of Premarket Notification [510(k)] Submission for Sharps Collectors dated October 1993", was also used.

Performance Testing (Bench) - Product Testing:

Puncture Resistance: Passed (ASTM F 2132-01 (2008))
Leak Resistance of bottom and sides: Passed (Based on OSHA Specification 29CFR 1910:1030)
Overfill detection and Capacity: Passed
Needle unwinder and recapper: Passed (Only applicable on 1 quart)
Impact resistance and safe handling: Passed (Based on ISO 23907:2012)
Sharps access, closure and minimization of aerosolization: Passed (Based on ISO 23907:2012)
Stability: Passed (Based on ISO 23907:2012)
Mounting Brackets usability and stability: Passed (Based on ISO 23907:2012)

The performance testing summary demonstrates substantial equivalence between the Oak Ridge Products devices and the predicate devices. No new issues of safety and effectiveness were raised.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K943575, K943659, K943660

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K', '1', '3', '0', 'Z', '8', and '1'. The characters are written in a simple, handwritten style.

Image /page/0/Picture/1 description: The image shows the logo for Oakridge Products. The word "OAKRIDGE" is in large, bold, black letters. Below that, the word "PRODUCTS" is in smaller, black letters. There is a black swoosh above the word "OAKRIDGE".

JUN 2 1 2013

510(k) Summary

Summary Preparation Date: May 15th, 2013

Submitted By

(Primary)

Contact Information

Oak Ridge Products L.L.C. 4612 Century Court McHenry, Illinois, 60050 USA Establishment Registration #:1419823

Tibor B. Kovari Quality Assurance Manager Oak Ridge Products L.L.C. 4612 Century Court McHenry, Illinois, 60050 USA

(815) 363-4700

Contact Information (Secondary)

Device identification:

Trade Name: Common Name: Product Code: Classification: CFR Reference: Classification Panel: Conor J. O'Malley Owner Oak Ridge Products L.L.C. 4612 Century Court McHenry, Illinois, 60050 USA comalley@oakridgeproducts.com (815) 363-4700

tkovari@oakridgeproducts.com

Oak Ridge Products Sharps Containers Sharps Container MMK Accessory to hypodermic single lumen needles 21 CFR 880 5570 - Class II General Hospital

Oak Ridge Products Sharps Containers

Revision 5

Image /page/1/Picture/0 description: The image shows the logo for Oakridge Products. The text "OAKRIDGE" is in large, bold, black letters. Below that, the text "PRODUCTS" is in smaller, bold, black letters. There is a black swoosh above the text.

4. Predicate devices:

Trade Name: Common Name: Product Code: Classification: CFR Reference: Classification Panel: B-D Guardian™ Nestable Sharps Collectors Sharps Container MMK Accessory to hypodermic single lumen needles 21 CFR 880.5570 - Class II General Hospital

Company	Product	510(k)#
Becton Dickinson	B-D Guardian™
Nestable Sharps
Collectors	K943575
Covidien (originally cleared
under Sage Products now
owned by Covidien)	Multi-purpose Sharps
Container	K943659
Covidien (originally cleared
under Sage Products now
owned by Covidien)	SharpSafety TM
Phlebotomy Containers	K943660

Legally Marketed Equivalent Devices:

5. Product Description:

Oak Ridge Products Sharps Containers

Image /page/2/Picture/0 description: The image shows the logo for OakRidge Products. The logo has the word "OAKRIDGE" in large, bold, black letters. Below that is the word "PRODUCTS" in smaller, black letters. There is a black swoosh above the word "OAKRIDGE".

General Specifications Table

| Part
Number | Product
Description | Access
opening
size | Access
opening
and
Closure | Overall Size
L x W x H
(inches) | Weight
(grams) | Capacity
at full
line |
|----------------|---------------------------------|---------------------------|-------------------------------------|---------------------------------------|-------------------|-----------------------------|
| 0310-
1500 | 1 Quart
Phlebotomy
RED | 2.0" x
1.5" | Slide | 4.5x4.5x7.5 | 115
grams | .8 quarts |
| 0354-
1100 | 5.4 quart
Universal
Clear | 8" x 1.4" | Rotating
Door | 11x4.5x10.5 | 340
grams | 4.3
quarts |
| 0354-
1500 | 5.4 quart
Universal
RED | 8" x 1.4" | Rotating
Door | 11x4.5x10.5 | 340
grams | 4.3
quarts |
| 0320-
1500 | 2 Gallon
Nestable
RED | 5.6" x
2.3" | Slide | 10.3x7x710.1 | 363
grams | 7.2
quarts |

Accessories

Oak Ridge Products offers a mountable locking bracket for the 1 quart Phlebotomy container. Oak Ridge Products part number #1010-9904.

Oak Ridge Products also offers several wall mountable locking accessories for the 5.4 quart container.

Manufacture	Part Number
Oak Ridge Products	"Press and Click" Locking Wall Bracket
with Key #1054-1300
Oak Ridge Products	"Swing Arm" Locking Wall Bracket #1054-
7300
Oak Ridge Products	Locking Wall Cabinet #1054-5300

All of the Oak Ridge Products Sharps Containers conform to the recognized standard ASTM F2132-01(2008) for needle puncture resistance. These also meet or exceed the OSHA 1910.1030 recommendations for sharps containers.

Image /page/3/Picture/0 description: The image shows the logo for Oakridge Products. The logo features the word "OAKRIDGE" in a bold, sans-serif font, with the word "PRODUCTS" in a smaller font underneath. A curved line extends from the left side of the word "OAKRIDGE" and arches over the top of the word.

6. Indications for Use:

| Part
Number | Product
Description | Access
opening
size | Access
opening
and
Closure | Length
(in) | Width
(in) | Height
(in) | Mounting |
|----------------|------------------------------|---------------------------|-------------------------------------|----------------|---------------|----------------|---------------------|
| 0310-
1500 | 1 Quart
Phlebotomy RED | 2.0" x 1.5" | Slide | 4.5" | 4.5" | 7.5" | Bracket required |
| 0354-
1100 | 5.4 quart
Universal Clear | 8" x 1.4" | Rotating
Door | 11" | 4.5" | 10.5" | Bracket
required |
| 0354-
1500 | 5.4 quart
Universal RED | 8" x 1.4" | Rotating
Door | 11" | 4.5" | 10.5" | Bracket
required |
| 0320-
1500 | 2 Gallon
Nestable RED | 5.6" x 2.3" | Slide | 10.3" | 7.0" | 10.1" | Free Standing |

The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device.

The 5.4 quart is intended to be used with an appropriate mounting device.

The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

7. Comparison to Predicate Devices:

Manufacturer	Oak Ridge Products	Becton Dickson®	Covidien®	Covidien®
Trade Name	Oak Ridge Products
Sharps Containers	B-D.Guardian™ Nestable
Sharps Collectors	SharpsSafety
'PHLEBOTOMY
SHARPS
DISPOSAL
CONTAINERS'	Multi-purpose
Sharps
Container
'ANCILLARY
AND LARGE
VOLUME
SHARPS
DISPOSAL
CONTAINERS'
510(k) number	K130281	K943575	K943660	K943659
Indication for use	Oak Ridge sharps
containers are
intended to be used
for the safe disposal
of hazardous sharps	B-D sharps containers are
intended to be used for the
safe disposal of hazardous
sharps	containers are
intended to be used
for the safe disposal
of hazardous sharps	containers are
intended to be
used for the safe
disposal of
hazardous sharps
Target Population	Healthcare
professional	Healthcare professional	Healthcare
professional	Healthcare
professional
Where used	Healthcare facilities	Healthcare facilities	Healthcare facilities	Healthcare
facilities
Material	Polypropylene	Polypropylene	Polypropylene	Polypropylene
Sharps access	Sharps inserted
through the top	Sharps inserted through the
top	Sharps inserted
through the top	Sharps inserted
through the top

Oak Ridge Products Sharps Containers

510(k) Summary Page 4 of 8

Image /page/4/Picture/0 description: The image shows the logo for Oakridge Products. The word "OAKRIDGE" is in large, bold, black letters. Below that, the word "PRODUCTS" is in smaller, black letters. There is a black swoosh above and below the words.

Manufacturer	Oak Ridge Products	Becton Dickson®	Covidien®	Covidien®
Sharps closure	Closure feature is
closed then locked in
place for removal	Flaps are closed and locked
in place for removal	Closure feature is
closed then locked in
place for removal	Closure feature is
closed then
locked in place
for removal
Impact resistance	Yes	Yes	Yes	Yes
Puncture resistance	Yes	Yes	Yes	Yes
Leak resistance	Yes	Yes	Yes	Yes
Single use	Yes	Yes	Yes	Yes
Non-sterile	Yes	Yes	Yes	Yes
Capable of
maintaining a
stable, upright
position	Yes	Yes	Yes	Yes
No features to
bend, break, or
shear needle.	No Feature Present	No Feature Present	No Feature Present	No Feature
Present
Reusable Sharps
Containers	Same	Labeling is "Single Use
Only"	Labeling is "Single
Use Only"	Labeling is
"Single Use
Only"
Overfill Indication	Same	"Do Not Overfill" or "Fill
to this Level Only" is
Labeled or embossed on the
container at the location of
the overfill. Labeling
includes a "Fill Line".	"Do Not Overfill" or
"Fill to this Level
Only" is Labeled or
embossed on the
container at the
location of the
overfill. Labeling
includes a "Fill
Line".	"Do Not Overfill"
or "Fill to this
Level Only" is
Labeled or
embossed on the
container at the
location of the
overfill. Labeling
includes a "Fill
Line".
Clarity	Same	Each Collector has a
minimum of one
translucent component.
either base or top.	Each Collector has a
minimum of one
translucent
component, either
base or top.	Each Collector
has a minimum of
one translucent
component. either
base or top.
Construction	Same	Injection Molded
Containers. Lids and
Closure	Injection Molded
Containers. Lids and
Closure	Injection Molded
Containers. Lids
and Closure

8. Substantial Equivalence Discussion of Similarities and Differences:

The Oak Ridge Products Sharps Containers are similar to the B-D Guardian™ Nestable Sharps containers in:

. Intended use
Target population .
Materials .
Design .
Performance testing .

Image /page/5/Picture/0 description: The image shows the logo for Oakridge Products. The word "OAKRIDGE" is in large, bold, black letters. Below that, the word "PRODUCTS" is in smaller, black letters. There is a black swoosh above the word "OAKRIDGE".

9. Intended use comparison:

The intended use of the new Oak Ridge Products Sharps Containers is the same as the predicate device. Oak Ridge Products Sharp Containers are containers intended for the disposal of contaminated medical waste in a healthcare facility.

10. Design and Material Comparison:

The design and functional characteristics of the Oak Ridge Products Sharps Containers and the predicate devices are similar. The Oak Ridge Products Sharps Containers parts are nestable and when assembled form a single unit. These units have features to prevent contact between user and the contents and are designed for a visual determination of the maximum capacity. None of the devices have features that bend, break, or shear needles. The devices are designed for a single use by a locking feature in the lids and closure or access door.

They are constructed of polymeric materials which is injection molded. The Oak Ridge Products Sharps Containers are constructed of only polypropylene. Oak Ridge Products Sharps Containers are either natural (uncolored) or colored red with translucent lids that allow for a visual determination of content level.

11. Summary of Non-Clinical Performance Bench Testing:

11.1 Performance Standards:

The Recognition Number 6-215 identifies ASTM F2132-01 (reapproved 2008), "Standard Specifications for puncture Resistance of Materials Used for the Collection for Discarded Medical Needles and Other Sharps."

The Recognition Number 6-293 identifies ISO 23907 First Edition 2012-09-01. "Sharps injury protection - Requirements and test methods - Sharps containers"

The performance testing demonstrates compliance with the recognized consensus standards, ASTM F2132-01 (reapproved 2008), "Standard Specifications for puncture Resistance of Materials Used for the Collection for Discarded Medical Needles and Other Sharps." and the applicable portions of ISO 23907 First Edition 2012-09-01, "Sharps injury protection - Requirements and test methods - Sharps containers"

In addition the relevant FDA guidance document, "Guidance on the Content and Format of Premarket Notification [510(k)] Submission for Sharps

Image /page/6/Picture/0 description: The image shows the logo for Oakridge Products. The logo is black and white and features the words "OAKRIDGE" in large, bold letters. Below the main text, the word "PRODUCTS" is written in a smaller font. A curved line extends over the top of the word "OAKRIDGE".

Collectors dated October 1993", was used to identify applicable physical and mechanical features of the Oak Ridge Products and predicate devices.

All applicable standards have been used to show that the Oak Ridge Products Sharps Container Family is substantially equivalent to the appropriately listed predicate device.

The performance testing summary demonstrates substantial equivalence between the Oak Ridge Products devices and the predicate devices. The Oak Ridge Products sharps containers have been tested by appropriate methods with respect to the relevant standards, FDA recognized ASTM standards F 2132-01 and OSHA requlations 29 CFR Part 1910:1030. No new issues of safety and effectiveness were raised with the testing performed, and the Oak Ridge Products Sharps containers are considered substantially equivalent to its predicate device.

11.2 Performance Testing (Bench) - Product Testing

The Oak Ridge Products Sharps Containers incorporate equivalent collector design features and performance characteristics.

The results of the product performance testing demonstrated equivalent performance to the predicate device performance and no new issues were raised.

Test Methods:

Puncture Resistance (Performed by and independent materials testing lab) -Passed

ASTM F 2132-01 (2008) "Standard Specification for the Puncture Resistance of Materials used in containers for the Discarded Medical Needles and Other Sharps".

Leak Resistance of bottom and sides Passed Based on OSHA Specification 29CFR 1910:1030
Overfill detection and Capacity: - Passed

Needle unwinder and recapper: - Only applicable on 1 quart - Passed

Impact resistance and safe handling - Passed Based on ISO 23907:2012

Image /page/7/Picture/0 description: The image shows the logo for Oakridge Products. The word "OAKRIDGE" is in large, bold, black letters. Below that, the word "PRODUCTS" is in smaller, black letters. There is a black swoosh above the word "OAKRIDGE".

Sharps access, closure and minimization of aerosolization : - Passed Based on ISO 23907:2012

Stability: - Passed Based on ISO 23907:2012

Mounting Brackets usability and stability: - Passed Based on ISO 23907:2012

11.3 Performance test summary:

The performance testing summary demonstrates substantial equivalence between the Oak Ridge Products devices and the predicate devices. The Oak Ridge Products sharps containers have been tested by appropriate methods with respect to the relevant standards, FDA recognized ASTM standards F 2132-01, OSHA regulations 29 CFR Part 1910:1030 and ISO 23907:2012(e). No new issues of safety and effectiveness were raised with the testing performed, and the Oak Ridge Products Sharps containers are considered substantially equivalent to its predicate device.

12. Conclusion:

The Oak Ridge Products Sharps Containers introduces no new questions concerning the safety or effectiveness and proves to be substantially equivalent to the respective predicate sharps collectors.

-B-D Guardian ™ Nestable Sharps Collector is a registered trademark of Becton, Dickinson and Company.

-BD® is a registered trademark of Becton, Dickinson and Company.

-SharpSafety™ is a trademark of the Covidien Company

Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 21, 2013

Oak Ridge Products, Limited Liability Company C/O Mark Job Regulatory Technology Services Limited Liability Company 1394 25th Street, N.W. BUFFALO MN 55313

Re: K130281

Trade/Device Name: Oak Ridge Products Sharps Containers Regulation Number: 21 CFR 880.5570 Regulation Name: Accessory to hypodermic single lumen Regulatory Class: Class II Product Code: MMK Dated: June 13, 2013 Received: June 14, 2013

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Page 2 - Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Runner
DOSINA Mary S.
Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/10/Picture/0 description: The image shows the logo for Oakridge Products. The logo features the words "OAKRIDGE" in large, bold, sans-serif font, with the word "PRODUCTS" in a smaller font size underneath. There is a decorative oval shape above the word "OAKRIDGE".

Traditional 510(k) submission

Section 4 Indications for Use

510(k) Number (if known): K130281

Device Name: Oak Ridge Products Sharps Containers

Model Numbers:

| Part
Number | Product
Description | Access
opening
size | Access
opening
and
Closure | Length
(in) | Width
(in) | Height(in) | Mounting |
|----------------|------------------------------|---------------------------|-------------------------------------|----------------|---------------|------------|---------------------|
| 0310-
1500 | 1 Quart
Phlebotomy RED | 2.0" x 1.5" | Slide | 4.5" | 4.5" | 7.5" | Bracket
required |
| 0354-
1100 | 5.4 quart
Universal Clear | 8" x 1.4" | Rotating
Door | 11" | 4.5" | 10.5" | Bracket
Required |
| 0354-
1500 | 5.4 quart
Universal RED | 8" x 1.4" | Rotating
Door | 11" | 4.5" | 10.5" | Bracket
Required |
| 0320-
1500 | 2 Gallon
Nestable RED | 5.6" x 2.3" | Slide | 10.3" | 7.0" | 10.1" | Free
Standing |

Indications for Use:

The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device.

The 5.4 quart is intended to be used with an appropriate mounting device.

The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Capitzation

2013.06.20

Page 1_ of 1

:Division Sion-Ji) ر

Olvision of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number:

Oak Ridge Products Sharps Containers

Revision 5