# K081468: Devilbiss Portable Oxygen Concentrator, 306 Series

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical
- Decided: Aug 25, 2008 after 90 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: 4 generations back to K933081 (1994). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013931: Omni Oxygen System, Model 1000, Sequal Technologies, Inc. (2002) Summary page 1.

## Most influential descendants
- K172648: Drive DeVilbiss iGo 2 Portable Oxygen Concentrator (2018), 0 descendants of its own
- K134023: 2300 Series Mgo Portable Oxygen (2014), 0 descendants of its own

## Indications for use
The Model 306 iGo Portable Oxygen Concentrator System is indicated for the administration of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K081468
Methodology: https://510kreport.com/methodology