K251744 is an FDA 510(k) clearance for the Affinity Pixie™ Arterial Filter with Balance™ Biosurface. This device is classified as a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II - Special Controls, product code DTM).
Submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on January 16, 2026, 224 days after receiving the submission on June 6, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4260.
| 510(k) Number | K251744 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2025 |
| Decision Date | January 16, 2026 |
| Days to Decision | 224 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4260 |