FDA 510(k) · CAIRE
K250671: FreeStyle Comfort (AS200 / FreeStyle Comfort) (Caire, Inc.)
Caire, Inc. received FDA 510(k) K250671 for FreeStyle Comfort (AS200 / FreeStyle Comfort), with a decision date of Jul 11, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K250671 |
|---|---|
| Pathway | 510(k) |
| Applicant | Caire, Inc. |
| Device name | FreeStyle Comfort (AS200 / FreeStyle Comfort) |
| Product code | CAW: Generator, Oxygen, Portable |
| Regulation (21 CFR) | 868.5440 |
| Device class | Class 2 |
| Date received | Mar 5, 2025 |
| Decision date | Jul 11, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Our labels for filtering: claim Other, sensor Unknown. These are heuristics, not FDA fields.