# K071904: Deployable Oxygen Generation System - Medium (Dogs-M)

- Pathway: 510(k) (Traditional)
- Applicant: Carleton Life Support Systems, Inc.
- Decided: Oct 25, 2007 after 107 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933081 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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.

## Indications for use
The DOGS-M system is intended to provide supplemental oxygen enriched gas to patients who may have difficulty extracting oxygen from air that they breathe. 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 military personnel. The DOGS-M has the capability to supply pressurized oxygen to fill gas cylinders that can be transported to remote locations away from the DOGS-M system or to fill cylinders for patient ambulatory use. The oxygen supplied by the DOGS-M 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/K071904
Methodology: https://510kreport.com/methodology