# K251607: Oxygen Concentrator (J5A)

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Kycare Medical Equipment Co., Ltd.
- Decided: Nov 21, 2025 after 178 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: 8 generations back to K933081 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240840: Oxygen Concentrator (ZY-10AB/115), Foshan Care Medical Technology Co., Ltd. (2024) Summary page 5.

## Indications for use
The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it's not intended to support or sustain life.

Source page: https://510kreport.com/device/K251607
Methodology: https://510kreport.com/methodology