# K053229: Merits Health Products Oxygen Concentrators

- Pathway: 510(k) (Special)
- Applicant: Merits Health Products Co., Ltd.
- Decided: Mar 23, 2006 after 125 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: 5 generations back to K933081 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011844: Merits Health Products Oxygen Concentrators, Merits Health Products., Inc. (2001) Summary page 1.
- K042262: Integra Oxygen Concentrator, Model 6323A-OM-10, Sequal Technologies, Inc. (2004) Summary page 1.
- K944020: Airsep Newlife Air Outlet Option, Airsep Corp. (1995) Summary page 1.

## Indications for use
The Oxygen Concentrators are indicated for the delivery of supplemental oxygen in the home or medical institutions. The devices are not intended for life support nor do they provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K053229
Methodology: https://510kreport.com/methodology