(88 days)
No
The device description explicitly states it is "Non-automated" and relies on a "manual method for detecting Korotkoff sounds." There is no mention of AI, ML, or any automated processing of data.
No.
The device is intended to measure blood pressure, which is a diagnostic function, not a therapeutic one. The description explicitly states it is a "non-invasive blood pressure measurement system for monitoring blood pressure levels."
Yes
An aneroid sphygmomanometer is used to measure blood pressure, which is a key vital sign that helps diagnose various medical conditions like hypertension or hypotension. By providing this measurement, the device aids in the diagnostic process.
No
The device description explicitly lists physical components such as an aneroid gauge, cuff, bladder, inflation bulb, and manometer, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Aneroid Sphygmomanometer measures blood pressure directly on the patient's body using a cuff and manual methods. It does not analyze any biological specimens.
- Intended Use: The intended use is to measure systolic and diastolic pressure on children and adults, which is a direct physiological measurement, not an in vitro test.
- Device Description: The description focuses on the mechanical components and the method of measurement (Korotkoff sounds), all of which are external to the body and do not involve analyzing biological samples.
Therefore, the Aneroid Sphygmomanometer, as described, falls under the category of a non-invasive medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds.
The Single Patient Use Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and 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)
DXO
Device Description
Aneroid Sphygmomanometer: The Aneroid Sphygmomanometer is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff and an aneroid sphygmomanometer to measure pressure. The proposed device is OTC, non-invasive, non-automated, and non-sterile.
The proposed device consists of an aneroid gauge, cuff, bladder, and inflation bulb. There are four models, including AS-ND-001, AS-ND-001LG, AS-ND-001CH, and AS-D-001. The differences between models are in the size, color, and material of the cuff.
Single Patient Use Aneroid Sphygmomanometer: The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. The proposed device is OTC, non-invasive, non-automated, and non-sterile.
The proposed device consists of a manometer, cuff, and inflation bulb. There are four models: AS-SPU-W, AS-SPU-Y, AS-SPU-LG, and AS-SPU-CH. The differences between models are in the size and color of the cuff.
Both types of aneroid sphygmomanometers use the same measurement method of the Korotkoff sounds method; they are all reusable same measurement range and accuracy. The single-patient use type is for single-patient multiple uses only to avoid cross infection. Both types of aneroid sphygmomanometer can be sold with/without optioned stethoscopes which have been listed with the FDA.
The proposed device is Over-The-Counter use, non-sterile, reusable device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper Arm
Indicated Patient Age Range
children and adults.
Intended User / Care Setting
healthcare facility by 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)
Non-Clinical Testing: Non-clinical testing was performed to verify substantial equivalence to the predicate device.
Performance: Non-invasive sphygmomanometers performance testing per ISO 81060-1:2007; ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type.
Biocompatibility: The biocompatibility evaluation for the patient contact reusable cuff was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing with a risk management process, September 4, 2020, and International Standard ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The testing items included: ISO 10993-5: 2009 In Vitro Cytotoxicity, ISO 10993-10: 2010 Skin Irritation, ISO 10993-10: 2010 Skin Sensitization.
Clinical Performance Data: No clinical data were required to demonstrate substantial equivalence.
Key results: The results of these tests demonstrate compliance with the requirements of the consensus standards noted below. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Aneroid Sphygmomanometer and Single Patient Use Aneroid Sphygmomanometer is substantially equivalent to the Cardicare Company, Ltd., Aneroid Sphygmomanometer With Stethoscope Model HBPK-A cleared under K082542 and the Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope, manufactured by Shanghai Caremate Medical Device Co. Ltd, cleared under K211084 concerning the indications for use, target populations, treatment method, and technological characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure +/-3mmHg of reading
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.
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
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November 28, 2022
Cardicare Company, Ltd. % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K222652
Trade/Device Name: Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: September 1, 2022 Received: September 1, 2022
Dear Charles Mack:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K222652
Device Name Aneroid Sphygmomanometer Single Patient Use Aneroid Sphygmomanometer
Indications for Use (Describe)
The Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds.
The Single Patient Use Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K
| Preparation Date: | September 2, 2022 |
|---|---|
| Manufacturer's Name and Address: | Cardicare Company, Ltd. |
| 9 Yan An Road, Wu Shan Plaza Town, Unit | |
| 7003, Hangzhou City, Zhejiang Province, China | |
| 310002 | |
| Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Aneroid Sphygmomanometer |
| Single Patient Use Aneroid Sphygmomanometer | |
| Common Name(s): | blood pressure cuff |
| Regulation Name(s): | Blood Pressure Cuff |
| Regulation Number(s): | 21CFR870.1120 |
| Product Code: | DXQ |
| Device Class: | Class II |
| Predicate Device: | |
| Reference Device: | Cardicare Company, Ltd.; K082542 |
| Shanghai Caremate Medical Device Co. Ltd; | |
| K211084 |
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Device Description:
Aneroid Sphygmomanometer
The Aneroid Sphygmomanometer is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff and an aneroid sphygmomanometer to measure pressure. The proposed device is OTC, non-invasive, non-automated, and non-sterile.
The proposed device consists of an aneroid qauge, cuff, bladder, and inflation bulb. There are four models, including AS-ND-001, AS-ND-001LG, AS-ND-001CH, and AS-D-001. The differences between models are in the size, color, and material of the cuff.
Single Patient Use Aneroid Sphygmomanometer
The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. The proposed device is OTC, non-invasive, non-automated, and non-sterile.
The proposed device consists of a manometer, cuff, and inflation bulb. There are four models: AS-SPU-W, AS-SPU-Y, AS-SPU-LG, and AS-SPU-CH. The differences between models are in the size and color of the cuff.
Both types of aneroid sphygmomanometers use the same measurement method of the Korotkoff sounds method; they are all reusable same measurement range and accuracy. The single-patient use type is for single-patient multiple uses only to avoid cross infection. Both types of aneroid sphygmomanometer can be sold with/without optioned stethoscopes which have been listed with the FDA.
The proposed device is Over-The-Counter use, non-sterile, reusable device.
Principles of Operation/Measurement Method:
Auscultatory Korotkoff sounds method
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| Characteristics | Subject Device | Primary Predicate Device | Reference Device | Discussion | |
|---|---|---|---|---|---|
| Device | Aneroid Sphygmomanometer | ||||
| Single Patient Use Aneroid | |||||
| Sphygmomanometer | Aneroid Sphygmomanometer | Aneroid Sphygmomanometer | - | ||
| Submitter | Cardicare Company, Ltd. | Cardicare Company, Ltd. | Shanghai Caremate Medical Device | ||
| Co. Ltd | - | ||||
| 510(K) Number | Pending | K082542 | K211084 | - | |
| Classification | 2 | 2 | 2 | Same | |
| Regulation Number | 870.1120 | 870.1120 | 870.1120 | Same | |
| Product Code | DXQ | DXQ | DXQ | Same | |
| Classification Name | Blood pressure cuff | Blood pressure cuff | Blood pressure cuff | Same | |
| K222652 | |||||
| Characteristics | Discussion | ||||
| Indication for Use | The Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. | The Aneroid Sphygmomanometer with Stethoscope, Model HBPK-A, is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure. This device is sold with an adult D size cuff and suitable for use on adults. | The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults and adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. | Note 1 | |
| The Single Patient Use Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. | Reusable | Same | |||
| Usage | Measurement Method | Korotkoff sounds method | Reusable | Same | |
| K222652 | |||||
| Characteristics | Subject Device | Primary Predicate Device | Reference Device | Discussion | |
| Patient Population | Children, young adults and adults | Adult | New borns, infants, children, young adults and adults | Note 2 | |
| OTC or Rx | OTC | OTC | OTC | Same | |
| Material | Manometer: Aluminum or Zinc+ABS | ||||
| Cuff: Nylon or cotton or PVC | |||||
| Bladder: PVC | |||||
| Tubing: PVC | |||||
| Hook: Nylon | |||||
| Loop: Nylon | Manometer: Zinc | ||||
| Cuff: Cotton or nylon | |||||
| Latex bladder: Latex or PVC | |||||
| The head of the stethoscope: Aluminum alloy | |||||
| The membrane of the stethoscope: PVC | |||||
| The tube of the stethoscope: PVC | Manometer: aluminum or ABS | ||||
| Tubing, inflation bulb, and cuff bladder: Neoprene or Silicon rubber or Nature latex or PVC | |||||
| Cuff: Nylon cloth for the outside layer | Note 3 | ||||
| Tube Quantity | 2 | 2 | 2 | Same | |
| Cuff Circumference (Range in mm) | Conforms to AHA bladder sizes recommendations: | ||||
| Fits arm circumferences 120 mm-508 mm. The standard cuff should be available to measure a child, adult, and adult with large arms. | Adult (with D ring): 24-32cm | Fits arm circumferences 100mm-620mm, the standard cuff should be available for use in measuring a Newborn, infant, or child's leg blood pressure and for a child, young adult, and adult with larger arms | Note 4 | ||
| K222652 | |||||
| Characteristics | Subject Device | Primary Predicate Device | Reference Device | Discussion | |
| Cuff Sizes | For Aneroid Sphygmomanometer cuff | ||||
| Adult: 53 x 14.5cm | |||||
| Large adult: 62 x 17.5cm | |||||
| Child: 34 x 11cm | |||||
| Adult (with D ring): 50 x 14cm |
For Single Patients, Use the Aneroid
Sphygmomanometer cuff
Adult: 53 x 15cm
Large Adult: 63 x 17.5cm
Child: 31 x 8.5 cm | Adult (with D ring): 50 x 14cm | 31.49" X 8.66" (800mm220mm)
24.41" × 6.89" (620mm175mm)
20.47" × 5.51" (520mm140mm)
13.4" x 4.33" (340mm110mm)
9.84"×3.15" (250mm80mm)
8.27" × 2.36" (210mm60mm ) | Note 5 | |
| Cuff Bladder
Size | For Aneroid Sphygmomanometer
Adult:22 x 12 cm
Large adult: 31 x 13.5 cm
Child: 17.5 x 8.5 cm
Adult (with D ring): 22 x 12cm
For Single Patient Use Aneroid
Sphygmomanometer
The cuff bladder is integrated with the
cuff. The device has no separate bladder. | Adult (with D ring): 22 x 12cm | 13.39" X 6.69" (340mm170mm)
12.2"×5.51" (310mm140mm)
8.66"×4.72" (220mm120mm)
6.69"×3.15" (170mm80mm)
4.33" x 2.36" (110mm60mm)
3.15" X 1.57" (80mm40mm) | Note 6 | |
| Pressure
Limits | 0-300mmHg | 0-300mmHg | 0-300mmHg | Same | |
| K222652 | Characteristics | Subject Device | Primary Predicate Device | Reference Device | Discussion |
| Accuracy | Pressure +/-3mmHg of reading | Pressure +/-3mmHg of reading | Pressure +/-3mmHg of reading | Same | |
| Anatomical Sites | Upper Arm | Upper Arm | Upper Arm (leg for child) | Same | |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same | |
| Inflation | Manual by inflation bulb | Manual by inflation bulb | Manual by inflation bulb | Same | |
| Deflation | Manual deflation via valve | Manual deflation via valve | Manual deflation via valve | Same | |
| Display | Aneroid Manometer | Aneroid Manometer | Aneroid Manometer | Same | |
| Performance | Conforms to ISO 81060-1 | Conforms to ISO 81060-1
(previous ANSI/AAMI SP10) | Conforms to ISO 81060-1 | Same | |
| Biocompatibility | Conforms to ISO10993-1 | Conforms to ISO10993-1 | Conforms to ISO10993-1 | Same | |
Comparison of Technological Characteristics with the Predicate Devic
K22652
6
7
8
9
10
Discussion:
Note 1: Indications for use
The subject devices, including the conventional type and single patient use type, are both reusable. The measurement method and intended use for both types are the same as our previously cleared predicate device and reference device, except the single-patients use type is for single-patient use only. Both conform to the same applicable performance standards.
The indication for use statement for the subject devices has been standardized to meet the requirements of most recently cleared devices under product code-DXQ and similar reference devices. The difference doesn't raise new questions of safety or effectiveness compared to the predicate.
Note 2: Patient Population
The tarqet population of the subject devices is larger than the predicate device but still covered by the reference devices, the same as most recently cleared aneroid sphygmomanometer devices.
They conform to the same performance standards (ISO81060-1). Therefore, the difference in the target population does not raise new questions on the safety and effectiveness of the subject device.
Note 3: Material
Although minor material differences exist among subject devices, predicate devices, and reference devices, they all conform to the same ISO10993-1 biocompatibility standards.
Note 4: Cuff circumference
The arm circumference for the proposed cuff is 120 mm-508 mm, and the arm circumference for the predicate cuff is 240-320 mm, the arm circumference for the reference cuff is 100 mm - 620 mm. The range of arm circumferences for the subject device is covered by the reference device, and they conform to the same performance standards; therefore, the difference in cuff circumference does not raise new questions on the safety and effectiveness of the subject device.
11
Note 5: Cuff sizes
The subject device's cuff sizes differ from the predicate and reference devices. However, the cuff size of the subject device is similar to the predicate device and the reference device. The Velcro on the cuff is designed to fit various arm circumferences. This difference doesn't raise new problems reqarding the safety and effectiveness of the subject device. Therefore, this difference in cuff size does not introduce new questions on the safety and efficacy of the subject device.
Note 6: Cuff bladder size
The cuff bladder size is similar to the predicate device and reference device for Aneroid Sphygmomanometer. It could fit various requirements of users. For Sinqle Patient Use of an Aneroid Sphygmomanometer, the cuff bladder is integrated with the cuff and has no separate bladder.
However, the subject devices conform to ISO 81060-1. Therefore, this difference in cuff bladder size does not raise new questions on the safety and effectiveness of the subject device.
Performance Testing
Performance testing was provided to support the substantial equivalence determination and to validate & verify that the subject devices met all requirements of related applicable standards. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
Non-Clinical Testing
Non-clinical testing was performed to verify substantial equivalence to the predicate device.
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K222652
Performance:
Non-invasive sphygmomanometers performance testing per ISO 81060-1:2007; ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
Biocompatibility:
The biocompatibility evaluation for the patient contact reusable cuff was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing with a risk management process, September 4, 2020, and International Standard ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The testing items included: ISO 10993-5: 2009 In Vitro Cytotoxicity ISO 10993-10: 2010 Skin Irritation
ISO 10993-10: 2010 Skin Sensitization
Clinical Performance Data
No clinical data were required to demonstrate substantial equivalence.
Conclusions:
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Aneroid Sphygmomanometer and Single Patient Use Aneroid Sphygmomanometer is substantially equivalent to the Cardicare Company, Ltd., Aneroid Sphygmomanometer With Stethoscope Model HBPK-A cleared under K082542 and the Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope, manufactured by Shanghai Caremate Medical Device Co. Ltd, cleared under K211084 concerning the indications for use, target populations, treatment method, and technological characteristics.
-END-