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Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)

by Microlife Corp.

510(k) K073398

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 · Special NumberK073398 Date20 Dec 2007ClearedStatusActive

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  • Withdrawn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
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.

This device is a wrist-worn blood pressure monitor designed for measuring blood pressure. It is identified as the Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100).

It is supplied as a consumer medical device for home use and has received FDA 510(k) clearance under product code DXN. The device was determined to be substantially equivalent to a predicate device, with clearance granted on December 20, 2007, under special 510(k) review by the Cardiovascular advisory committee.

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Questions

AI-generated answers, 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.

  • What is the Microlife Wrist Watch Blood Pressure Monitor BP3MK1-3 used for?

    This device is designed for measuring blood pressure in a home setting. It is worn on the wrist and provides blood pressure readings for personal health monitoring, as stated in its description as a consumer medical device for home use.

  • How is the Microlife BP3MK1-3 supplied and is it reusable?

    The device is supplied as a consumer medical device for home use. It is intended for repeated personal use by an individual, as it is a wearable monitor designed for ongoing home blood pressure tracking, not as a single-use disposable product.

  • What regulatory pathway was used for the Microlife BP3MK1-3 and when was it cleared?

    The device received FDA 510(k) clearance under product code DXN, determined to be substantially equivalent to a predicate device. Clearance was granted on December 20, 2007, following a special 510(k) review by the Cardiovascular advisory committee.