K251367 is an FDA 510(k) clearance for the OptoMonitor 3. This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).
Submitted by Opsens, Inc. (Quebec, CA). The FDA issued a Cleared decision on January 16, 2026, 260 days after receiving the submission on May 1, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K251367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2025 |
| Decision Date | January 16, 2026 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXO - Transducer, Pressure, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2870 |