# K011844: Merits Health Products Oxygen Concentrators

- Pathway: 510(k) (Traditional)
- Applicant: Merits Health Products., Inc.
- Decided: Aug 28, 2001 after 77 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 K933081 (1994). 5 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955549: Oxlife Oxygen Concentrators, Oxlife, Inc. (1996) Summary page 1.
- K971964: Oxlife Excell Oxygen Concentrators, Oxlife, Inc. (1997) Summary page 1.
- K960309: Airsep Newlife Dual Six Oxygen Concentrator (Modification), Airsep Corp. (1997) Summary page 1.
- K904087: Mobilaire Iii and V Model Irc 301 and 501 Oxy. Con, Invacare Corp. (1990) Summary page 1.

## Most influential descendants
- 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
- K041664: Portable Oxygen Generation System: Pogs 33C (2004), 3 descendants of its own

## Indications for use
The Oxygen Concentrator is indicated for the delivery of supplemental oxygen in the home or medical institutions. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K011844
Methodology: https://510kreport.com/methodology