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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 / January 2026 / K253671

510(k) cleared

Dual Stage Venous Cannulae

Sorin Group Italia S.R.L. · Jan 30, 2026 · K253671

FDA cleared the Dual Stage Venous Cannulae from Sorin Group Italia S.R.L. on Jan 30, 2026 under K253671, a traditional 510(k). The device falls under product code DWF, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, regulated at 21 CFR 870.4210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 21, 2025. The decision came 70 days later, inside the 90 FDA-day goal for a 510(k).

Sorin Group Italia S.R.L. has 2 other decisions in the tracker over the last 12 months: K251783 (Inspire HCR and HCR DUAL cardiotomy reservoirs), K253616 (ProtekDilate Vascular Access Kit).

Questions & Answers

What did FDA clear under K253671?

K253671 is the FDA 510(k) for Dual Stage Venous Cannulae, submitted by Sorin Group Italia S.R.L.. FDA's decision date was Jan 30, 2026, under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).

Who makes the Dual Stage Venous Cannulae?

Sorin Group Italia S.R.L., based in Mirandola, is the applicant of record for K253671.

How long did the K253671 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Jan 30, 2026, 70 days later.

← All decisions in January 2026

Sources