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Automated Non-Invasive Blood Pressure Monitor, Model BPM-100

by Vsm Medtech, Ltd.

510(k) K994423

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 NumberK994423 Date28 Mar 2000ClearedStatusActive

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  • Withdrawn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
FDA applicant
Vsm Medtech , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

An automated non-invasive blood pressure monitor is a device that measures systolic and diastolic blood pressure and pulse rate using oscillometric measurement principles. It processes pressure signals to derive blood pressure and heart rate values for clinician review.

This device is used in clinical environments such as physicians' offices and hospitals by healthcare professionals. It is supplied as a reusable device and has received FDA 510(k) clearance under product code DXN, with K number K994423 and decision date March 28, 2000.

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