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BPC-3000 Personal Blood Pressure Communicator, Model 52520

by Welch Allyn, Inc.

510(k) K001543

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 NumberK001543 Date29 Jan 2001ClearedStatusActive

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  • Withdrawn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 BPC-3000 Personal Blood Pressure Communicator, Model 52520, is a non-invasive blood pressure measurement system designed for home or personal use. It falls under the classification of a blood pressure measurement device, intended to provide accurate systolic and diastolic readings through cuff-based technology.

This device is supplied as a reusable system and operates in home or clinical settings where blood pressure monitoring is required. It has received FDA 510(k) clearance under product code DXN, classified as a Class II device under traditional review. No specific sterility or MRI safety information is provided in the available data.

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Questions

AI-generated answers, 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.

  • Is the BPC-3000 Personal Blood Pressure Communicator designed for single-use or can it be reused over time?

    The BPC-3000 is explicitly described as a reusable blood pressure measurement system, intended for use in both home and clinical settings. Since it is not labeled as single-use or sterile, it is meant for repeated use by the same user or in a shared clinical environment, provided proper hygiene practices are followed.

  • What type of regulatory clearance does the BPC-3000 have, and how was it reviewed?

    The BPC-3000 received FDA 510(k) clearance under product code DXN, classified as a Class II device. It underwent traditional review by the Cardiovascular (CV) Advisory Committee and was determined to be substantially equivalent to a predicate device. The clearance was granted on January 29, 2001.

  • Can this device be used in a hospital or clinical setting, or is it only for home use?

    While the BPC-3000 is primarily marketed for home or personal use, its reusable design and lack of specific sterility restrictions suggest it could also be used in clinical settings where blood pressure monitoring is required—provided proper cleaning and maintenance protocols are followed. However, hospitals may have their own policies regarding non-invasive blood pressure devices.

  • Does the BPC-3000 provide both systolic and diastolic readings, and how is the measurement taken?

    Yes, the BPC-3000 is designed to provide accurate systolic and diastolic blood pressure readings using cuff-based technology, which is the standard method for non-invasive blood pressure measurement. The cuff inflates around the upper arm to measure arterial pressure indirectly.