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DeVilbiss 125D-BT-R

by DeVilbiss Healthcare LLC.

DeVilbiss 125D-BT-R is a Class II device made by DeVilbiss Healthcare LLC., cleared under FDA 510(k) K172648 on 23 Mar 2018 and listed in FDA GUDID since 20 Aug 2026 (UDI-DI 00885304035848), active as of 22 Oct 2026. One FDA recall is 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

1 ongoing

This device is named in the recall

Documents

510(k) K172648

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 Number00885304035848 UDI-DI Date20 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172648 Date23 Mar 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172648 decided 23 Mar 2018 Active
  • FDA GUDID UDI-DI 00885304035848 listed 20 Aug 2026 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0229-2023 FDA Class II initiated 19 Sep 2022

    An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)

Timeline

3 dated events

  1. Cleared FDA 510(k) K172648
  2. Recall initiated FDA recalls Z-0229-2023
  3. Listed FDA GUDID 00885304035848

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  • Withdrawn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
Mobile/portable oxygen concentrator
Model / Ref / Catalog
125D-BT-R
Primary DI / UDI-DI
00885304035848
510(k) Number
FDA product code
CAW
GMDN term
Mobile/portable oxygen concentrator
Device class
Class II
Regulation number
868.5440
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Height — 8.4 Inch
Width — 3.5 Inch
Length — 8.6 Inch

Related devices

Cleared under the same submission (K172648)

and 2 more cleared under K172648

Other devices from DeVilbiss Healthcare LLC.

See all devices from DeVilbiss Healthcare LLC. →

Properties

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