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Disposable NIBP Cuff

by Shenzhen Changke Connect Electronics Co., Ltd.

510(k) K193629

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193629↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK193629 Date25 Mar 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193629 decided 25 Mar 2020 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 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 Disposable Non-Invasive Blood Pressure Cuff is a single-use medical device designed for measuring blood pressure without invasive procedures. Classified under the nomenclature for blood pressure measurement devices, it utilises a cuff-based oscillometric method to estimate systolic and diastolic pressure via arterial pulsations.

Supplied in single-use packaging, this cuff is intended for one-time clinical or veterinary use and must be discarded after use. Authorised under FDA 510(k) clearance (K193629) and MDR compliance, it is available in multiple sizes, including adult (25–35 cm) and veterinary variants. Non-woven material construction ensures sterility and hygiene, with no MRI safety restrictions specified.

Similar devices

Other devices filed under FDA product code DXQ (Blood Pressure Cuff).

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