# K043615: Oxytec, Model 900

- Pathway: 510(k) (Traditional)
- Applicant: Oxytec Medical Corporation
- Decided: Feb 9, 2005 after 41 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 K020324 (2002). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020324: Lifestyle Oxygen Concentrator, Airsep Corp. (2002) Summary page 1.

## Most influential descendants
- K121260: Trooper Oxygen Concentrator (2012), 1 descendant of its own
- K200496: Aer X (2020), 0 descendants of its own
- K102750: O2-in-a-Box, O2-in-a-Box (2011), 0 descendants of its own

## Indications for use
The OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments.

Source page: https://510kreport.com/device/K043615
Methodology: https://510kreport.com/methodology