# K955549: Oxlife Oxygen Concentrators

- Pathway: 510(k) (Traditional)
- Applicant: Oxlife, Inc.
- Decided: Mar 15, 1996 after 101 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: 1 generation back to K933081 (1994). 1 ancestor in all.
59 later devices descend from it; 4 cite it directly.
4 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933081: Oxlife Oxygen Concentrator, Oxlife, Inc. (1994) Summary page 1.

## Most influential descendants
- K963042: Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 (1996), 42 descendants of its own
- K013931: Omni Oxygen System, Model 1000 (2002), 38 descendants of its own
- K083163: Omni 2 Oxygen System (2009), 18 descendants of its own
- K011844: Merits Health Products Oxygen Concentrators (2001), 16 descendants of its own
- K014078: ON Site Gas Systems Portable Oxygen Generator System (2002), 13 descendants of its own

## Indications for use
The OxLife oxygen concentrators are intended to provide supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K955549
Methodology: https://510kreport.com/methodology