# K253549: DeVilbiss 5 Liter Oxygen Concentrator (555)

- Pathway: 510(k) (Traditional)
- Applicant: Devilbiss Healthcare, LLC
- Decided: Mar 26, 2026 after 132 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 K953815 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230969: Oxygen Concentrator, Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (2023) Summary page 5.

## Indications for use
The DeVilbiss 5 Liter (555) Oxygen Concentrator is intended to provide supplemental oxygen to adult patients requiring oxygen therapy. The device may be used in the home or an institutional setting. The device is not intended to be life sustaining or life supporting.

Source page: https://510kreport.com/device/K253549
Methodology: https://510kreport.com/methodology