K250671 is an FDA 510(k) clearance for the FreeStyle Comfort (AS200 / FreeStyle Comfort). This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Caire, Inc. (Ball Ground, US). The FDA issued a Cleared decision on July 11, 2025, 128 days after receiving the submission on March 5, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K250671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2025 |
| Decision Date | July 11, 2025 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAW - Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |