# K053230: Merits Health Products Oxygen Concentrators

- Pathway: 510(k) (Traditional)
- Applicant: Merits Health Products Co., Ltd.
- Decided: May 16, 2006 after 179 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: 4 generations back to K933081 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971947: Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853 (with AC Power Supply Accessory), Sim Italia S.R.L. (1997) Summary page 1.

## Indications for use
The Oxygen Concentrators are indicated for provide supplemental oxygen when the patient is away from their primary home oxygen source. The devices are not intended for life support nor do they provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K053230
Methodology: https://510kreport.com/methodology