# K250671: FreeStyle Comfort (AS200 / FreeStyle Comfort)

- Pathway: 510(k) (Traditional)
- Applicant: Caire, Inc.
- Decided: Jul 11, 2025 after 128 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: 2 generations back to K203086 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222086: Inogen Rove 4 Portable Oxygen Concentrator, Inogen (2022) Summary page 5.

## Indications for use
The FreeStyle Comfort Oxygen Concentrator can deliver concentrated oxygen with either a fixed-minute pulse delivery or can be set to operate using autoSAT pulse delivery. The FreeStyle Comfort is used on a prescriptive basis by patients requiring supplemental oxygen to increase blood oxygen saturation. FreeStyle Comfort may be used in the home, institution, and transport modes.

Source page: https://510kreport.com/device/K250671
Methodology: https://510kreport.com/methodology