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Atlan A350 8621500

by Drägerwerk AG & Co. KGaA

Ref 8621500Model 301035FK19T010

Atlan A350 8621500 is a device classified as Class IIb in the EU and Class II in the US made by Drägerwerk AG & Co. KGaA, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 040486751301035FK19T010V2), cleared under FDA 510(k) K230931 on 23 Jul 2023 and listed in FDA GUDID since 21 Sep 2023 (UDI-DI 04048675556176), active as of 12 Nov 2026. 9 FDA recalls are 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

9 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230931

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number040486751301035FK19T010V2 Basic UDI-DI 04048675556176UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048675556176 UDI-DI Date21 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230931 Date23 Jul 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 040486751301035FK19T010V2 registered 27 May 2026 Active
  • FDA 510(k) K230931 decided 23 Jul 2023 Active
  • FDA GUDID UDI-DI 04048675556176 listed 21 Sep 2023 Listed

Recalls

9 recalls · 9 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-2208-2026 FDA Class I initiated 7 May 2026
    • Ongoing Z-2207-2026 FDA Class I initiated 7 May 2026
    • Ongoing Z-0304-2025 FDA Class I initiated 15 Oct 2024
    • Ongoing Z-0667-2025 FDA Class I initiated 15 Oct 2024
    • Ongoing Z-0305-2025 FDA Class I initiated 15 Oct 2024
    • Ongoing Z-0668-2025 FDA Class I initiated 15 Oct 2024

    The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

  • 2 recalls, same reason

    • Ongoing Z-2617-2025 FDA Class I initiated 9 Sep 2025
    • Ongoing Z-2616-2025 FDA Class I initiated 9 Sep 2025

    The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

    • Ongoing Z-0971-2024 FDA Class II initiated 17 Nov 2023

    Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.

Timeline

12 dated events

  1. Recall initiated FDA recalls Z-0971-2024
  2. Recall initiated FDA recalls Z-0304-2025
  3. Recall initiated FDA recalls Z-0667-2025
  4. Recall initiated FDA recalls Z-0305-2025
  5. Recall initiated FDA recalls Z-0668-2025
  6. Recall initiated FDA recalls Z-2617-2025
  7. Recall initiated FDA recalls Z-2616-2025
  8. Recall initiated FDA recalls Z-2208-2026
  9. Recall initiated FDA recalls Z-2207-2026
  10. Registered EUDAMED 040486751301035FK19T010V2

2 earlier events are in the sections above.

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
Atlan A350
Generic name
Anaesthesia workstation, general-purpose
Model / reference
8621500, 301035FK19T010
Primary DI / UDI-DI
04048675556176
Basic UDI-DI
040486751301035FK19T010V2
Direct marketing DI
04048675556176
510(k) Number
FDA product code
BSZ
EMDN code
Z1203010101 Anaesthesia devices
GMDN term
Anaesthesia workstation, general-purpose
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5160
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Anaesthesia workstation, general-purpose

Cleared under the same submission (K230931)

Similar devices in this category

Other devices filed under ANAESTHESIA DEVICES.

Other devices from Drägerwerk AG & Co. KGaA

See all devices from Drägerwerk AG & Co. KGaA →

Properties

  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Administering medicine
  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)