# K014301: Modification to Merits Health Products Oxygen Concentrators

- Pathway: 510(k) (Special)
- Applicant: Merits Health Products Co., Ltd.
- Decided: Feb 11, 2002 after 42 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: 3 generations back to K933081 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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). Our OCR of the scanned summary read K011884, FDA’s number for Powdered Synthetic Vinyl Patient Examination Gloves (Shijiazhuang Eversharp Plastic Products Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “5-liter Merits Health Products Oxygen Concentrators”.

## Indications for use
The Oxygen Concentrators are 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/K014301
Methodology: https://510kreport.com/methodology