K252541 is an FDA 510(k) clearance for the Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W. This device is classified as a Heat-exchanger, Cardiopulmonary Bypass (Class II - Special Controls, product code DTR).
Submitted by Spectrum Medical S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on March 12, 2026, 212 days after receiving the submission on August 12, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4240.
| 510(k) Number | K252541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTR — Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4240 |