510(k) K251783

Inspire HCR and HCR DUAL cardiotomy reservoirs by Sorin Group Italia S.R.L. — Product Code DTN

K251783 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "Inspire HCR and HCR DUAL cardiotomy reservoirs". The FDA issued a decision of Substantially Equivalent on December 22, 2025. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.