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DeVilbiss 1025UK

by DeVilbiss Healthcare LLC.

Ref 1025UK

DeVilbiss 1025UK is a device classified as Class IIa in the EU and Class II in the US made by DeVilbiss Healthcare LLC., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00885304022480), cleared under FDA 510(k) K071397 on 1 Oct 2007 and listed in FDA GUDID since 17 Aug 2017 (UDI-DI 00885304022480), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 7 Nov 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

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) K071397

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00885304022480 Basic UDI-DI 00885304022480UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885304022480 UDI-DI Date17 Aug 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK071397 Date1 Oct 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00885304022480 registered 30 Oct 2026 Active
  • FDA 510(k) K071397 decided 1 Oct 2007 Active
  • FDA GUDID UDI-DI 00885304022480 listed 17 Aug 2017 Listed

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-1727-2025 FDA Class I initiated 11 Apr 2025

    Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.

    • Ongoing Z-1558-2023 FDA Class II initiated 9 Mar 2023

    The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

    • Ongoing Z-0724-2023 FDA Class II initiated 18 Nov 2022

    The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.

Timeline

6 dated events

  1. Cleared FDA 510(k) K071397
  2. Listed FDA GUDID 00885304022480
  3. Recall initiated FDA recalls Z-0724-2023
  4. Recall initiated FDA recalls Z-1558-2023
  5. Recall initiated FDA recalls Z-1727-2025
  6. Registered EUDAMED B-00885304022480

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
10 liter Stationary Oxygen Concentrator EUDAMED
DeVilbiss GUDID
Generic name
Stationary oxygen concentrator
Device name
Stationary Oxygen Concentrator
Model / Ref / Catalog
1025UK
Primary DI / UDI-DI
00885304022480
Basic UDI-DI
B-00885304022480
510(k) Number
FDA product code
CAW
EMDN code
R060202 Oxygen administration humidification systems
GMDN term
Stationary oxygen concentrator
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5440
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
Not 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 (K071397)

and 4 more cleared under K071397

Similar devices in this category

Other devices filed under OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS.

Other devices from DeVilbiss Healthcare LLC.

See all devices from DeVilbiss Healthcare LLC. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)