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Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3P

by Microlife Intellectual Property GmbH

510(k) K120430

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 NumberK120430 Date2 Aug 2012ClearedStatusActive

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  • Withdrawn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, 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 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 BP3MO1-3P.

It was submitted for regulatory review by Microlife Intellectual Property GmbH and received a 510(k) clearance from the FDA. The device was found substantially equivalent to a predicate device, with clearance granted on August 2, 2012, under product code DXN and advisory committee classification CV (cardiovascular).

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See all devices from Microlife Intellectual Property GmbH →

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.

  • What is the Microlife Wrist Watch Blood Pressure Monitor BP3MO1-3P used for?

    It is designed for measuring blood pressure in a wrist-worn format, allowing users to monitor their blood pressure conveniently at home or in clinical settings.

  • How is the Microlife Wrist Watch Blood Pressure Monitor BP3MO1-3P supplied?

    The device is supplied as a single wrist-worn unit, model BP3MO1-3P, intended for personal use and includes the monitor itself as described in the submission.

  • Is the Microlife Wrist Watch Blood Pressure Monitor BP3MO1-3P sterile or single-use?

    The device is not sterile and is designed for repeated use; it is a reusable electronic monitor that does not require sterilization between uses.

  • What regulatory pathway was used for the Microlife Wrist Watch Blood Pressure Monitor BP3MO1-3P?

    It received FDA 510(k) clearance on August 2, 2012, under k-number K120430, based on a finding of substantial equivalence to a predicate device.

  • What are the key identifiers for the Microlife Wrist Watch Blood Pressure Monitor BP3MO1-3P?

    The device is identified by its name, model number BP3MO1-3P, product code DXN, and was submitted by Microlife Intellectual Property GmbH with FDA clearance granted in 2012.