Skip to content

Aircraft Medical Oxygen Generation System (Amogs)

by Carleton Life Support Systems, Inc.

510(k) K082829

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082829 Date22 Dec 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2009-2009 FDA Unclassified (pre-2012) initiated 24 Jul 2009 on shared 510(k) K082829

    The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLF
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Carleton Life Support Systems, Inc.