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DECO, 5L Oxygen Concentrator 5DECO2DS

by Drive Devilbiss Healthcare

DECO, 5L Oxygen Concentrator 5DECO2DS is a Class II device made by Drive Devilbiss Healthcare, cleared under FDA 510(k) K090007 on 24 Jul 2009 and listed in FDA GUDID since 29 Oct 2026 (UDI-DI 00822383027180), active as of 9 Nov 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 9 Nov 2026

Documents

510(k) K090007

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00822383027180 UDI-DI Date29 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090007 Date24 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090007 decided 24 Jul 2009 Active
  • FDA GUDID UDI-DI 00822383027180 listed 29 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090007
  2. Listed FDA GUDID 00822383027180

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DECO, 5L Oxygen Concentrator
Generic name
Mobile/portable oxygen concentrator
Model / reference
5DECO2DS
Primary DI / UDI-DI
00822383027180
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

Related devices

Cleared under the same submission (K090007)

and 1 more cleared under K090007

Other devices from Drive Devilbiss Healthcare

See all devices from Drive Devilbiss Healthcare →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)