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Cardio Server 901204

by Welch Allyn, Inc.

Ref 901204-V7XModel 901204

Cardio Server 901204 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 19 Oct 2026 (Basic UDI-DI 0732094GMN901204EY), cleared under FDA 510(k) K052883 on 1 Nov 2005 and listed in FDA GUDID since 18 Dec 2025 (UDI-DI 00732094360295), active as of 23 Oct 2026. One FDA recall is linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K052883

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732094GMN901204EY Basic UDI-DI 00732094360295UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00732094360295 UDI-DI Date18 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK052883 Date1 Nov 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0732094GMN901204EY registered 19 Oct 2026 Active
  • FDA 510(k) K052883 decided 1 Nov 2005 Active
  • FDA GUDID UDI-DI 00732094360295 listed 18 Dec 2025 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2647-2023 FDA Class II initiated 10 Aug 2023

    Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.

Timeline

4 dated events

  1. Cleared FDA 510(k) K052883
  2. Recall initiated FDA recalls Z-2647-2023
  3. Listed FDA GUDID 00732094360295
  4. Registered EUDAMED 0732094GMN901204EY

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Cardio Server
Generic name
Cardiology information system application software
Model / reference
901204, 901204-V7X
Primary DI / UDI-DI
00732094360295
Basic UDI-DI
0732094GMN901204EY
510(k) Number
FDA product code
DQK
EMDN code
Z12050392 Electrocardiographs - medical device software
GMDN term
Cardiology information system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1425
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
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

Cleared under the same submission (K052883)

and 6 more cleared under K052883

Similar devices in this category

Other devices filed under ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE.

Other devices from Welch Allyn, Inc.

See all devices from Welch Allyn, Inc. →

Properties

  • Measuring function
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)