ANEROID SPHYGMOMANOMETER, MODEL BK2002

K043286 · Wenzhou Bokang Instrument Co.,Ltd · DXQ · Jan 13, 2005 · Cardiovascular

Device Facts

• Record ID: K043286
• Device Name: ANEROID SPHYGMOMANOMETER, MODEL BK2002
• Applicant: Wenzhou Bokang Instrument Co.,Ltd
• Product Code: DXQ · Cardiovascular
• Decision Date: Jan 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

Aneroid sphygmomanometer for non-invasive blood pressure measurement; consists of inelastic cuff with inflatable bladder, tubing, and manual inflation mechanism; used by medical professionals or patients in home settings; operator manually inflates cuff and uses external method (e.g., stethoscope) to detect Korotkoff sounds; provides pressure readings via analog gauge; aids clinical decision-making regarding hypertension management.

Clinical Evidence

Bench testing only. Device tested for conformance to ANSI/AAMI SP-9 standard for non-automated sphygmomanometers.

Technological Characteristics

Manual aneroid sphygmomanometer; inelastic cuff with hook and loop closure; inflatable bladder; manual inflation bulb; analog pressure gauge; no electronic components or software; conforms to ANSI/AAMI SP-9.

Indications for Use

Indicated for measurement of systolic and diastolic blood pressure in adults by medical professionals or in home settings.

Regulatory Classification

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.

Predicate Devices

• Nihon Seimitsu Sokki Co.,Ltd model HT-110 (K012194)

Submission Summary (Full Text)

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## JAN 1 3 2005

510(K) submission,Aneroid Sphygmomanometer Wenzhou Bokang Instrument Co.,Ltd P.R.China

## 510(K) Summary

| Contact | Zhen Hui<br>Zhejiang ML Medical Device Consultant Co.,Ltd<br>23#,Huanchengdong Road,Hangzhou,310009<br>P.R.China<br>Tel:[phone]<br>Fax:[phone] |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Xiang Youwang<br>Wenzhou Bokang Instrument Co.,Ltd<br>72#,Haibin Ningchen Hengjie,Wenzhou,325024<br>P.R.China<br>Tel:[phone]<br>Fax:[phone] |
| 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<br>section | Product<br>code | Class | Tier |
|---------------------|------------------------|-----------------|---------------|------|
| Blood Pressure,Cuff | 870.1120 | DXQ | II | 2 |
| Stethoscope | 870.1875<br>(optional) | I.DE | I<br>(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.

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| | Indication For Use The device is intended to be used by medical professionals or in the<br>home for the measurement of systonic and diastonic pressure on<br>adults. The device is intended to be manually attached to a patient and<br>manually inflated along with a manual method for detecting<br>Korotkoff sounds. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The Bokang's Aneroid Sphygmomanometer BK2002 is virtually the<br>same as Nihon Seimitsu Sokki Co.,Ltd's model HT-110 |
| Performance | The Aneroid Sphygmomanometer BK2002 has been tested to<br>conform to the ANSI/AAMI standard SP-9,Non-automated<br>sphygmomanometer. |
| Conclusion | In accordance with the Federal Food,Drug and Cosmetic Act,21CFR<br>Part 807 and based on the information provided in this premarket<br>notification,Wenzhou Bokang Instrument Co.,Ltd concludes that the<br>Aneroid Sphygmomanometer BK2002 is safe and effective,and<br>substantially equivalent to the predicate device described herein. |
| Others | Wenzhou Bokang Instrument Co.,Ltd will update and include in this<br>summary any other informations needed by FDA. |

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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.

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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 [phone] 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 [phone] or [phone] 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

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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