K251245 is an FDA 510(k) clearance for the OxyMinder Pro (10310). This device is classified as a Analyzer, Gas, Oxygen, Gaseous-phase (Class II - Special Controls, product code CCL).
Submitted by Bio-Med Device, Inc. (Guilford, US). The FDA issued a Cleared decision on August 11, 2025, 111 days after receiving the submission on April 22, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1720.
| 510(k) Number | K251245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2025 |
| Decision Date | August 11, 2025 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCL - Analyzer, Gas, Oxygen, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1720 |