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Welch Allyn, Inc. 901085

by Welch Allyn, Inc. 15 variants

Welch Allyn, Inc. 901085 (TM55LEXRCE) is a Class II device made by Welch Allyn, Inc., cleared under FDA 510(k) K152944 on 6 Jan 2016 and listed in FDA GUDID since 1 Jul 2019 (UDI-DI 00732094261455), active as of 23 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

510(k) K152944

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00732094261455 UDI-DI Date1 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152944 Date6 Jan 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152944 decided 6 Jan 2016 Active
  • FDA GUDID UDI-DI 00732094261455 listed 1 Jul 2019 Listed

Recalls

5 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0321-2025 FDA Class II initiated 11 Oct 2024
    • Ongoing Z-0325-2025 FDA Class II initiated 11 Oct 2024

    There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

  • 2 recalls, same reason

    • Ongoing Z-0706-2024 FDA Class II initiated 8 Dec 2023
    • Ongoing Z-0705-2024 FDA Class II initiated 8 Dec 2023

    Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

    • Terminated Z-1817-2020 FDA Class II initiated 18 Mar 2020

    Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Timeline

7 dated events

  1. Cleared FDA 510(k) K152944
  2. Listed FDA GUDID 00732094261455
  3. Recall initiated FDA recalls Z-1817-2020
  4. Recall initiated FDA recalls Z-0706-2024
  5. Recall initiated FDA recalls Z-0705-2024
  6. Recall initiated FDA recalls Z-0321-2025
  7. Recall initiated FDA recalls Z-0325-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Welch Allyn, Inc.
Generic name
Electrocardiographic lead set, reusable
Model / Ref / Catalog
901085, TM55LEXRCE
Primary DI / UDI-DI
00732094261455
510(k) Number
FDA product code
DPS
GMDN term
Electrocardiographic lead set, reusable
Device class
Class II
Regulation number
870.2340
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiographic lead set, reusable

Cleared under the same submission (K152944)

and 8 more cleared under K152944

Similar devices in this category

Other devices filed under Electrocardiographic lead set, reusable.

Other devices from Welch Allyn, Inc.

See all devices from Welch Allyn, Inc. →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)