# K091716: Merits Health Products Profil Q601 Series Oxygen Filling Accessory

- Pathway: 510(k) (Special)
- Applicant: Merits Health Products Co., Ltd.
- Decided: Apr 2, 2010 after 296 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 K003939 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050430: Merits Health Products Oxygen Concentrator, Merits Health Products Co., Ltd. (2005) Summary page 1.

## 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/K091716
Methodology: https://510kreport.com/methodology