# K050430: Merits Health Products Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Merits Health Products Co., Ltd.
- Decided: Aug 4, 2005 after 167 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: 1 generation back to K003939 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003939: Venture Home Fill II, Model Ioh 200, Invacare Corp. (2001) Summary page 1.

## Most influential descendants
- K091716: Merits Health Products Profil Q601 Series Oxygen Filling Accessory (2010), 0 descendants of its own

## Indications for use
The Oxygen Concentrators with the Oxygen Filling accessory are indicated to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended for life support nor does it provide any patient monitoring capabilities

Source page: https://510kreport.com/device/K050430
Methodology: https://510kreport.com/methodology