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SIMO2, Portable Oxygen Concentrator SIMO2DS

by Drive Devilbiss Healthcare

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) K230969

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00822383035482 UDI-DI Date29 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230969 Date9 Nov 2023DecidedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0795-2025 FDA Class I initiated 9 Dec 2024

    Oxygen concentrator may melt or catch on fire during use.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SIMO2, Portable Oxygen Concentrator
Generic name
Mobile/portable oxygen concentrator
Model / reference
SIMO2DS
Primary DI / UDI-DI
00822383035482
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 (K230969)

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)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Expiration date: No