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Hand Aneroid Sphygmomanometer

by Welch Allyn, Inc.

510(k) K940493

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 NumberK940493 Date1 Jul 1994ClearedStatusActive

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  • Withdrawn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
DXQ
Device Class
Class II
Regulation
21 CFR Part 870.1120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Hand Aneroid Sphygmomanometer is a manually operated device that measures arterial blood pressure using an aneroid gauge. It provides clinicians with a non‑electronic method to assess patient blood pressure in a variety of settings.

The device received traditional FDA 510(k) clearance (K940493) on July 1 1994 and is classified as substantially equivalent to a predicate device. It is supplied by Welch Allyn, Inc. under product code DXQ and is a reusable instrument intended for clinical use.

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