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Pulsonic Digital Blood Pressure Monitor Model BP-3

by Healthcheck Corp.

510(k) K860287

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 NumberK860287 Date28 Apr 1986ClearedStatusActive

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  • Withdrawn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, 19 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 Pulsonic Digital Blood Pressure Monitor Model BP-3 is a non-invasive, digital device designed for measuring blood pressure. Classified under the nomenclature for systems, measurement, blood-pressure, non-invasive, it provides automated readings of systolic and diastolic pressure via oscillometric technology.

This device is intended for single-use or reusable clinical settings, depending on manufacturer guidelines, and has received FDA 510(k) clearance (K860287) under the Traditional pathway. Supplied as a Class II medical device, it adheres to Regulation 870.1130 and is regulated under the Cardiovascular review panel. No third-party review was conducted.

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