# K222086: Inogen Rove 4 Portable Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Inogen
- Decided: Dec 9, 2022 after 147 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 K203086 (2021). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203086: X-PLO2R, Belluscura, LLC (2021) Summary page 4.

## Most influential descendants
- K230052: Inogen Rove 6 (2023), 8 descendants of its own
- K254289: Portable Oxygen Concentrator (OX-1A-E, OX-1B) (2026), 0 descendants of its own
- K260171: Portable Oxygen Concentrator (PO1 5B, PO1 6B) (2026), 0 descendants of its own
- K252399: Portable Oxygen Concentrator (2026), 0 descendants of its own
- K252407: OxyGo Portable Oxygen Concentrator (1400-7000) (2026), 0 descendants of its own

## Indications for use
The Inogen Rove™ 4 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

Source page: https://510kreport.com/device/K222086
Methodology: https://510kreport.com/methodology