# K172648: Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Devilbiss Healthcare, LLC
- Decided: Mar 23, 2018 after 203 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: 5 generations back to K933081 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081468: Devilbiss Portable Oxygen Concentrator, 306 Series, Sunrise Medical (2008) Summary page 4.

## Recalls of this device
- Sep 19, 2022 · Class II · Z-0229-2023: An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)

## Indications for use
The Drive DeVilbiss iGo2 Portable Oxygen Concentrator 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/K172648
Methodology: https://510kreport.com/methodology