# K113317: Lifechoice Oxygen Concentrator

- Pathway: 510(k) (Special)
- Applicant: Inova Labs, Inc.
- Decided: Dec 28, 2011 after 48 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 K020324 (2002). 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)
- K072688: Lifechoice Oxygen Concentrator, Model OXY1000, International Biophysics Corp. (2008) Summary page 1.

## Indications for use
The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining, It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.

Source page: https://510kreport.com/device/K113317
Methodology: https://510kreport.com/methodology