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DeVilbiss 1025DS-R

by DeVilbiss Healthcare LLC.

DeVilbiss 1025DS-R is a Class II device made by DeVilbiss Healthcare LLC., cleared under FDA 510(k) K071397 on 1 Oct 2007 and listed in FDA GUDID since 20 Aug 2026 (UDI-DI 00885304035824), active as of 22 Oct 2026. 3 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

3 ongoing

This device is named in the recall

Documents

510(k) K071397

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885304035824 UDI-DI Date20 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK071397 Date1 Oct 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K071397 decided 1 Oct 2007 Active
  • FDA GUDID UDI-DI 00885304035824 listed 20 Aug 2026 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

5 dated events

  1. Cleared FDA 510(k) K071397
  2. Recall initiated FDA recalls Z-0724-2023
  3. Recall initiated FDA recalls Z-1558-2023
  4. Recall initiated FDA recalls Z-1727-2025
  5. Listed FDA GUDID 00885304035824

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DeVilbiss
Generic name
Stationary oxygen concentrator
Model / Ref / Catalog
1025DS-R
Primary DI / UDI-DI
00885304035824
510(k) Number
FDA product code
CAW
GMDN term
Stationary oxygen concentrator
Device class
Class II
Regulation number
868.5440
GUDID distribution status
In Commercial Distribution
Size
Height — 24.5 Inch
Width — 13.5 Inch
Length — 12.0 Inch

Related devices

Cleared under the same submission (K071397)

and 3 more cleared under K071397

Other devices from DeVilbiss Healthcare LLC.

See all devices from DeVilbiss Healthcare LLC. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)