# K250805: DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)

- Pathway: 510(k) (Traditional)
- Applicant: Devilbiss Healthcare, LLC
- Decided: Dec 9, 2025 after 267 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 PulmO2 10-Liter Oxygen Concentrator is intended to provide supplemental oxygen to adult and pediatric patients >10kg 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/K250805
Methodology: https://510kreport.com/methodology