# K132205: Actovox DUO2 Oxygen Concentrator System

- Pathway: 510(k) (Traditional)
- Applicant: Inova Labs, Inc.
- Decided: Jun 6, 2014 after 325 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 K972614 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061261: L4 Oxygen Concentrator, Respironics, Inc. (2006) Summary page 1.
- K072688: Lifechoice Oxygen Concentrator, Model OXY1000, International Biophysics Corp. (2008) Summary page 5.

## Indications for use
Activox DU02 Oxygen Concentrator System is used on a prescriptive basis by adult patients who are diagnosed as requiring supplemental oxygen. The 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 or institutional/hospital setting.

Source page: https://510kreport.com/device/K132205
Methodology: https://510kreport.com/methodology