# K182454: O2 Concepts Oxlife Independence Model 301-0001

- Pathway: 510(k) (Traditional)
- Applicant: O2 Concepts, LLC
- Decided: Dec 20, 2018 after 104 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: 4 generations back to K933081 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013931: Omni Oxygen System, Model 1000, Sequal Technologies, Inc. (2002) Summary page 4.

## Indications for use
The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration of supplemental oxygen. It is not intended for life support, nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K182454
Methodology: https://510kreport.com/methodology