# K960309: Airsep Newlife Dual Six Oxygen Concentrator (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Airsep Corp.
- Decided: Feb 28, 1997 after 420 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
No predicates in its family tree.
17 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- 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
- K020362: P.O.G.S. 3.3 Portable Oxygen Generator System (2002), 6 descendants of its own
- K020330: Deployable Oxygen Concentration System (Docs) (2002), 5 descendants of its own
- K030920: POGS 33 (2004), 4 descendants of its own

Source page: https://510kreport.com/device/K960309
Methodology: https://510kreport.com/methodology