(48 days)
Not Found
No
The description details a manual sphygmomanometer, which relies on manual inflation and detection of Korotkoff sounds, with no mention of automated analysis or AI/ML components.
No.
The device is described as a non-invasive sphygmomanometer used for measuring blood pressure, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as measuring systolic and diastolic pressure, which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly details physical components like tubing, a sleeve, an inflatable bladder, and a sphygmomanometer, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device measures blood pressure by applying external pressure to a limb and detecting Korotkoff sounds. It does not analyze any biological samples taken from the patient.
- Intended Use: The intended use is to measure systolic and diastolic pressure on adults, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, based on the provided information, this device is a non-invasive blood pressure monitor and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to be used by medical professionals or in the home for the measurement of systonic and diastonic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
Product codes (comma separated list FDA assigned to the subject device)
DXQ, I.DE
Device Description
The device comproses tubing attached to a soft ineastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive sphygmomaniometer.
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
adults
Intended User / Care Setting
medical professionals or in the home
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 Aneroid Sphygmomanometer BK2002 has been tested to conform to the ANSI/AAMI standard SP-9, Non-automated sphygmomanometer.
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.
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
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).
0
JAN 1 3 2005
510(K) submission,Aneroid Sphygmomanometer Wenzhou Bokang Instrument Co.,Ltd P.R.China
510(K) Summary
| Contact | Zhen Hui
Zhejiang ML Medical Device Consultant Co.,Ltd
23#,Huanchengdong Road,Hangzhou,310009
P.R.China
Tel:+86-571-87044795
Fax:+86-571-87046982 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Xiang Youwang
Wenzhou Bokang Instrument Co.,Ltd
72#,Haibin Ningchen Hengjie,Wenzhou,325024
P.R.China
Tel:+86-577-86873588
Fax:+86-577-86880123 |
| Proprietary Name | Aneroid Sphygmomanometer BK2002 |
| Common Name | Aneroid Sphygmomanometer BK2002 |
| Classification Name | Blood Pressure, Cuff |
| Panel | Cardiovascular |
| Classification | The classification Name 21 CFR Part and Paragraph num |
ne,21 CFR Part and Paragraph number,Product code and classification of Aneroid Sphygmomanometer BK2002 and stethoscope are as follows.The tier categorization is also included.
| classification name | 21 CFR
section | Product
code | Class | Tier |
|---------------------|------------------------|-----------------|---------------|------|
| Blood Pressure,Cuff | 870.1120 | DXQ | II | 2 |
| Stethoscope | 870.1875
(optional) | I.DE | I
(exempt) | 1 |
Predicate Device The Bokang's Aneroid Sphygmomanometer BK2002 is substantially equivalent to Nihon Seimitsu Sokki Co.,Ltd's model HT-110 which 510(K) number is K012194
Device Description The device comproses tubing attached to a soft ineastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive sphygmomaniometer.
1
| | Indication For Use The device is intended to be used by medical professionals or in the
home for the measurement of systonic and diastonic pressure on
adults. The device is intended to be manually attached to a patient and
manually inflated along with a manual method for detecting
Korotkoff sounds. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The Bokang's Aneroid Sphygmomanometer BK2002 is virtually the
same as Nihon Seimitsu Sokki Co.,Ltd's model HT-110 |
| Performance | The Aneroid Sphygmomanometer BK2002 has been tested to
conform to the ANSI/AAMI standard SP-9,Non-automated
sphygmomanometer. |
| Conclusion | In accordance with the Federal Food,Drug and Cosmetic Act,21CFR
Part 807 and based on the information provided in this premarket
notification,Wenzhou Bokang Instrument Co.,Ltd concludes that the
Aneroid Sphygmomanometer BK2002 is safe and effective,and
substantially equivalent to the predicate device described herein. |
| Others | Wenzhou Bokang Instrument Co.,Ltd will update and include in this
summary any other informations needed by FDA. |
:
:
:
2
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem that resembles an eagle or a similar bird, depicted in a stylized, abstract manner.
JAN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wenzhou Bokang Instrument Co. Ltd. c/o Mr. Tzu-Wei Li Manager Center for Measurement Standards/Industrial Technology Research Institute Bldg. 16, 321 Kuang Fu Rd. Sec. 2 Hsinchu, Taiwan 30042 R.O.C.
Re: K043286
Trade Name: Aneroid Sphygmomanometer BK2002 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: December 29, 2004 Received: January 05, 2005
Dear Mr. Li:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Tzu-Wei Li
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bzumma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
RE: Review of BK2002 - OMDE 930705 BY: Sandy Liu DA: 01/03/05
Page Page _of
(043286)
510(k) Number (if known): __ K043286
Device Name: Aneroid Sphygmomanometer BK2002
Indications For Use:
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use V (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BÉLOW THIS LINE-CONTINUE ON NOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K04/3286
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number