# K061261: L4 Oxygen Concentrator

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Jun 28, 2006 after 54 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: 1 generation back to K972614 (1998). 1 ancestor in all.
6 later devices descend from it; 5 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972614: Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605, Healthdyne Technologies, Inc. (1998) Summary page 1.

## Most influential descendants
- K082566: Mark 5 Nuvo Lite Ocsi and STD (2008), 1 descendant of its own
- K213825: Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A (2023), 0 descendants of its own
- K132489: Inogen at Home Oxygen Concentrator (Aka Inogen at Home) (2014), 0 descendants of its own
- K132205: Actovox DUO2 Oxygen Concentrator System (2014), 0 descendants of its own
- K123738: Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STD (2013), 0 descendants of its own

## Indications for use
The L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining For use in the home or hospital/institutional environment.

Source page: https://510kreport.com/device/K061261
Methodology: https://510kreport.com/methodology