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Minhua Disposable Blood Pressure Cuff

by Suzhou Minhua Medical Apparatus

510(k) K143728

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK143728 Date15 May 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXQ
Device Class
Class II
Regulation
21 CFR Part 870.1120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Minhua Disposable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure monitoring systems for the determination of a person's blood pressure. This device is designed for single-patient use to assist in the prevention of cross-infection during clinical monitoring.

The cuff is manufactured from soft fabric materials and features a rounded corner design for patient comfort. It is supplied as a disposable medical device and is subject to FDA 510K authorization under K-number K143728.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the Minhua Blood Pressure Cuff intended for multiple patients?

    No, this device is designed specifically for single-patient use. This design choice is intended to assist in the prevention of cross-infection during clinical monitoring procedures.

  • What is the primary function of this cuff?

    The Minhua Disposable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure monitoring systems to determine a patient's blood pressure levels.

  • What regulatory authorization does this device hold?

    The Minhua Disposable Blood Pressure Cuff is subject to FDA 510K authorization under K-number K143728, which indicates it has been found substantially equivalent to predicate devices.

  • What materials are used in the construction of this cuff?

    The cuff is manufactured from soft fabric materials and features a rounded corner design. These features are specifically incorporated to enhance patient comfort during the monitoring process.