# K240840: Oxygen Concentrator (ZY-10AB/115)

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Care Medical Technology Co., Ltd.
- Decided: Dec 6, 2024 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: 7 generations back to K933081 (1994). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222920: Oxygen concentrator, Zhengzhou Olive Electronic Technology Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K251534: Oxygen Concentrator (J10A) (2025), 0 descendants of its own
- K251607: Oxygen Concentrator (J5A) (2025), 0 descendants of its own

## 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/K240840
Methodology: https://510kreport.com/methodology