K242503 is an FDA 510(k) clearance for the Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232). This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Eurosets S.R.L (Medolla, IT). The FDA issued a Cleared decision on November 24, 2025, 459 days after receiving the submission on August 22, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K242503 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2024 |
| Decision Date | November 24, 2025 |
| Days to Decision | 459 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTZ - Oxygenator, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4350 |