# K081267: Hygeia-5 Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Kedl Internation Limited
- Decided: Sep 23, 2008 after 141 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 K953815 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991722: Devilbiss 5 Liter Oxygen Concentrator, Sunrise Medical Hhg, Inc. (1999) Summary page 1.
- K942082: Model 6323 Oxygen Concentrator, Dynotec Corp. (1994) Summary page 1.

## Indications for use
The Hygeia-5 Oxygen concentrators are indicated to provide supplemental oxygen for adults requiring supplemental oxygen and are intended to be used in the home or institutional environment. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K081267
Methodology: https://510kreport.com/methodology