# K081508: HG Oxygen Concentrator, Models HG5-W & HG5-WN

- Pathway: 510(k) (Traditional)
- Applicant: Shenyang Canta Medical Tech. Co., Ltd.
- Decided: Aug 27, 2008 after 90 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: 2 generations back to K020324 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073242: Portable Oxygen Concentrator, Model RS-00400, Delphi Medical Systems (2008) Summary page 2.

## Indications for use
HG Oxygen concentrator is intended to provide supplemental oxygen to patient continuously in home, hospital or health care facility environments. It is not for supporting or sustaining life.

Source page: https://510kreport.com/device/K081508
Methodology: https://510kreport.com/methodology