# K102245: Care ZY5BA Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Care Medical Technology Co., Ltd.
- Decided: Nov 9, 2010 after 92 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 K883591 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071608: A&J POCA01 Oxygen Concentrator, Zhongshan A&J Medical Equipment Co., Ltd. (2008) Summary page 1.

## Indications for use
The CARE ZY51BA Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The CARE ZY5BA Oxygen Concentrator is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.

Source page: https://510kreport.com/device/K102245
Methodology: https://510kreport.com/methodology