# K172234: Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Sysmed (China) Co., Ltd.
- Decided: Jun 1, 2018 after 311 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 K933081 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150930: Deployable Oxygen Generation System-Smaill (DOGS-S), Airsep Corporation (2015) Summary page 5.

## Indications for use
The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.

Source page: https://510kreport.com/device/K172234
Methodology: https://510kreport.com/methodology