# K251534: Oxygen Concentrator (J10A)

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Kycare Medical Equipment Co., Ltd.
- Decided: Dec 29, 2025 after 224 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 provide supplemental oxygen to patients who require supplemental O2, 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.

Source page: https://510kreport.com/device/K251534
Methodology: https://510kreport.com/methodology