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DeVilbiss 555KS

by DeVilbiss Healthcare LLC.

DeVilbiss 555KS is a Class II device made by DeVilbiss Healthcare LLC., cleared under FDA 510(k) K253549 on 26 Mar 2026 and listed in FDA GUDID since 12 May 2026 (UDI-DI 00885304034841), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K253549

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 Number00885304034841 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253549 Date26 Mar 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253549 decided 26 Mar 2026 Active
  • FDA GUDID UDI-DI 00885304034841 listed 12 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253549
  2. Listed FDA GUDID 00885304034841

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  • Withdrawn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
555KS
Primary DI / UDI-DI
00885304034841
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

Related devices

Cleared under the same submission (K253549)

Other devices from DeVilbiss Healthcare LLC.

See all devices from DeVilbiss Healthcare LLC. →

Properties

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