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Welch Allyn, Inc. 901058

by Welch Allyn, Inc. 47 variants

Ref 71XTModel 901058

Welch Allyn, Inc. 901058 (71XT) is a device classified as Class IIa in the EU and Class II in the US made by Welch Allyn, Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-00732094196832), cleared under FDA 510(k) K142356 on 19 Dec 2014 and listed in FDA GUDID since 11 Sep 2023 (UDI-DI 00732094196832), active as of 24 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142356

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00732094196832 Basic UDI-DI 00732094196832UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00732094196832 UDI-DI Date11 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142356 Date19 Dec 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00732094196832 registered 20 Oct 2026 Active
  • FDA 510(k) K142356 decided 19 Dec 2014 Active
  • FDA GUDID UDI-DI 00732094196832 listed 11 Sep 2023 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1565-2025 FDA Class II initiated 21 Mar 2025
    • Ongoing Z-1564-2025 FDA Class II initiated 21 Mar 2025 on shared 510(k) K142356

    Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

    • Ongoing Z-2581-2023 FDA Class II initiated 10 Aug 2023

    Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

6 dated events

  1. Cleared FDA 510(k) K142356
  2. Recall initiated FDA recalls Z-2581-2023
  3. Listed FDA GUDID 00732094196832
  4. Recall initiated FDA recalls Z-1565-2025
  5. Recall initiated FDA recalls Z-1564-2025
  6. Registered EUDAMED B-00732094196832

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Welch Allyn Connex Spot Monitor EUDAMED
Welch Allyn, Inc. GUDID
Generic name
Multiple physiological parameter spot-check system, clinical
Device name
Vital Signs Monitor Core
Model / Ref / Catalog
901058, 71XT
Description
VS CSM NIBP SureTemp
Primary DI / UDI-DI
00732094196832
Basic UDI-DI
B-00732094196832
510(k) Number
FDA product code
MWI
EMDN code
Z1203020202 Transportable/portable multi–parameter patient monitors
GMDN term
Multiple physiological parameter spot-check system, clinical
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2300
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multiple physiological parameter spot-check system, clinical

Cleared under the same submission (K142356)

and 8 more cleared under K142356

Similar devices in this category

Other devices filed under TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS.

Other devices from Welch Allyn, Inc.

See all devices from Welch Allyn, Inc. →

Properties

  • Measuring function
  • Serial number
Other properties (23, all answered No)