# K953815: 5 LPM Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Devilbiss Health Care, Inc.
- Decided: Nov 9, 1995 after 87 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
No predicates in its family tree.
15 later devices descend from it; 2 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991722: Devilbiss 5 Liter Oxygen Concentrator (1999), 14 descendants of its own
- 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

Source page: https://510kreport.com/device/K953815
Methodology: https://510kreport.com/methodology