# K033863: OX-Gen Flexible O2 Generation System, Model 6-OX-03

- Pathway: 510(k) (Traditional)
- Applicant: Ox-Gen, Inc.
- Decided: Aug 22, 2005 after 619 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: 2 generations back to K780020 (1978). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780020: Generator, Oxygen, Portable, Jet Research Center, Inc. (1978) Summary page 1.
- K982243: Canogen Portable Oxygen Generator Model 615, Canogen International, Ltd. (1998) Summary page 1.

## Indications for use
The OX-GEN Rigid 02 Generation System, Model 5-OX-03 is intended to produce oxygen for emergency use.

Source page: https://510kreport.com/device/K033863
Methodology: https://510kreport.com/methodology