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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K251783

510(k) cleared

Inspire HCR and HCR DUAL cardiotomy reservoirs

Sorin Group Italia S.R.L. · Dec 22, 2025 · K251783

FDA cleared the Inspire HCR and HCR DUAL cardiotomy reservoirs from Sorin Group Italia S.R.L. on Dec 22, 2025 under K251783, a traditional 510(k). The device falls under product code DTN, Reservoir, Blood, Cardiopulmonary Bypass, regulated at 21 CFR 870.4400 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 11, 2025. The decision came 194 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sorin Group Italia S.R.L. has 2 other decisions in the tracker over the last 12 months: K253671 (Dual Stage Venous Cannulae), K253616 (ProtekDilate Vascular Access Kit).

Questions & Answers

What did FDA clear under K251783?

K251783 is the FDA 510(k) for Inspire HCR and HCR DUAL cardiotomy reservoirs, submitted by Sorin Group Italia S.R.L.. FDA's decision date was Dec 22, 2025, under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass).

Who makes the Inspire HCR and HCR DUAL cardiotomy reservoirs?

Sorin Group Italia S.R.L., based in Mirandola (Modena), is the applicant of record for K251783.

How long did the K251783 review take?

FDA received the submission on Jun 11, 2025 and issued its decision on Dec 22, 2025, 194 days later.

← All decisions in December 2025

Sources