# K252965: Oxygen Concentrator (OX-5A, OX-5C)

- Pathway: 510(k) (Traditional)
- Applicant: Oxytek Medical Technology Co., Ltd.
- Decided: May 29, 2026 after 254 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: 6 generations back to K953815 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230969: Oxygen Concentrator, Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (2023) Summary page 5.

## Indications for use
The oxygen concentrator provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life. The intended patient should be 22 years old and above.

Source page: https://510kreport.com/device/K252965
Methodology: https://510kreport.com/methodology