K254278 is an FDA 510(k) clearance for the Arterial Pressure Monitoring Set/Tray. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Spectrum Vascular (White Plains, US). The FDA issued a Cleared decision on March 25, 2026, 85 days after receiving the submission on December 30, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K254278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2025 |
| Decision Date | March 25, 2026 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO - Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |