# K991722: Devilbiss 5 Liter Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical Hhg, Inc.
- Decided: Nov 3, 1999 after 167 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953815 (1995). 1 ancestor in all.
14 later devices descend from it; 3 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953815: 5 LPM Oxygen Concentrator, Devilbiss Health Care, Inc. (1995) Summary page 1.

## Most influential descendants
- K020386: Invacare Platinum, Models Irc 5LX and Irc 5LX02 (2002), 12 descendants of its own
- K033405: Longfei Lfy-I-5 Oxygen Concentrator (2005), 5 descendants of its own
- K090007: Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 (2009), 4 descendants of its own
- K230969: Oxygen Concentrator (2023), 3 descendants of its own
- K061426: Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 (2006), 2 descendants of its own

## Recalls of this device
- Oct 30, 2008 · Not classified · Z-0617-2009: potential for sieve beds to have been incorrectly assembled

## Indications for use
The DeVilbiss 5 Liter Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc.

Source page: https://510kreport.com/device/K991722
Methodology: https://510kreport.com/methodology