Submission Details
| 510(k) Number | K251783 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 11, 2025 |
| Decision Date | December 22, 2025 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Inspire HCR and HCR DUAL cardiotomy reservoirs
Dec 2025
Decision
194d
Days
Class 2
Risk
About This 510(k) Submission
K251783 is an FDA 510(k) clearance for the Inspire HCR and HCR DUAL cardiotomy reservoirs, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Sorin Group Italia S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on December 22, 2025, 194 days after receiving the submission on June 11, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.
Device Classification
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4400 |
Manufacturer
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