CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF

K031416 · Clearmedical, Inc. · DXQ · Jul 15, 2003 · Cardiovascular

Device Facts

• Record ID: K031416
• Device Name: CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF
• Applicant: Clearmedical, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Jul 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The ClearMedical Blood Pressure Cuff is indicated for use in manual measurement and automatic non-invasive blood pressure (BP) monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual BP measurement The for ass with manometers sure Cuff is intended as a single patient use item.

Device Story

ClearMedical Blood Pressure Cuff functions as a component of non-invasive blood pressure monitoring systems. Device connects to manometers or automated inflation systems to facilitate blood pressure measurement. Intended for single-patient use in clinical settings; operated by trained personnel. Provides a pneumatic interface for pressure measurement; aids healthcare providers in obtaining patient blood pressure readings for clinical assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Blood pressure cuff for non-invasive monitoring; single-patient use design; compatible with standard manometers and automated inflation systems; Class II device (21 CFR 870.1120).

Indications for Use

Indicated for manual or automatic non-invasive blood pressure monitoring in patients by trained personnel. Designed for single-patient use.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2003

Clear Medical, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462

Re: K031416

Trade Name: ClearMedical Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood pressure cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: June 27, 2003 Received: June 30, 2003

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of July 15, 2003 regarding the incorrect address.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3 rotty premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Citiestic) to regars manetical Device Amendments or to Conimeres prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, alla Cosmedic Act (Act) that do fict required controls provisions of the Act. The general therefore, market the devices and genere to generation, listing of devices, controls provisions of the receined requirences against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc above) into the regulations affecting your device can be

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Page 2 - Mr. Robert Mosenkis

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loaso be actived a a determination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any I odetar bullated and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFA rat 607), adoning (21 OFF Part 820); and if applicable, the electronic forth in the quality by bound (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) This letter will anow you to common ting of substantial equivalence of your device to a legally premated notineation. The 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 and 11 you dolly Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance additionally For 00110 isonally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Statement of Indications for Use

510(k) Number:

## KD31416

Device:

7 #

ClearMedical Blood Pressure Cuff

The ClearMedical Blood Pressure Cuff is indicated for use in manual measurement and automatic non-invasive blood pressure (BP) monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual BP measurement The for ass with manometers sure Cuff is intended as a single patient use item.

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number