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Microlife Wrist Watch Blood Pressure Monitor BP3GK1-4B

by Microlife Intellectual Property GmbH

510(k) K211288

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 NumberK211288 Date4 Nov 2021ClearedStatusActive

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  • Withdrawn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)

Full name
Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is a digital device designed to measure blood pressure. It provides automated readings for individuals monitoring their cardiovascular health.

This device is supplied as a single unit and has received FDA 510K clearance. It is identified by K-number K211288 and is classified under product code DXN.

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