# K082829: Aircraft Medical Oxygen Generation System (Amogs)

- Pathway: 510(k) (Traditional)
- Applicant: Carleton Life Support Systems, Inc.
- Decided: Dec 22, 2008 after 88 days
- Product code: OLF (Medevac Use Oxygen Generator)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933081 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020330: Deployable Oxygen Concentration System (Docs), Pacific Consolidated Industries Llp (2002) Summary page 1.
- K971889: Chad Total O2 Delivery System, Chad Therapeutics, Inc. (1997) Summary page 1.

## Recalls of this device
- Jul 24, 2009 · Not classified · Z-2009-2009: The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.

## Indications for use
The AMOGS system is intended to provide oxygen enriched gas generated by the pressure swing adsorption process to patients who may have difficulty extracting oxygen from air that they breathe while on board the HH-60M MEDEVAC helicopter. The system may be used to provide medical support to the full spectrum of deployed scenarios including wartime operations, deterrence and contingency operations, peacetime engagement, crisis response and humanitarian relief operations by trained personnel. The oxygen supplied by the AMOGS is supplemental and is not considered to be life supporting or life sustaining. This device is not intended to be used in the presence of flammable anesthetics nor is it intended to be sterilized. There are no contraindications.

Source page: https://510kreport.com/device/K082829
Methodology: https://510kreport.com/methodology