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A&D Medical Ua-767PBT Digital Blood Pressure Monitor

by A&D Engineering, Inc.

510(k) K043217

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK043217 Date3 Mar 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0063-2017 FDA Class II initiated 12 Sep 2016

    A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.

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  • Withdrawn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

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