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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 / K253616

510(k) cleared

ProtekDilate Vascular Access Kit

Sorin Group Italia S.R.L. · Dec 19, 2025 · K253616

FDA cleared the ProtekDilate Vascular Access Kit from Sorin Group Italia S.R.L. on Dec 19, 2025 under K253616, a special 510(k). The device falls under product code DRE, Dilator, Vessel, For Percutaneous Catheterization, regulated at 21 CFR 870.1310 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 18, 2025. The decision came 31 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: K253671 (Dual Stage Venous Cannulae), K251783 (Inspire HCR and HCR DUAL cardiotomy reservoirs).

Questions & Answers

What did FDA clear under K253616?

K253616 is the FDA 510(k) for ProtekDilate Vascular Access Kit, submitted by Sorin Group Italia S.R.L.. FDA's decision date was Dec 19, 2025, under product code DRE (Dilator, Vessel, For Percutaneous Catheterization).

Who makes the ProtekDilate Vascular Access Kit?

Sorin Group Italia S.R.L., based in Mirandola ( Modena), is the applicant of record for K253616.

How long did the K253616 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Dec 19, 2025, 31 days later.

← All decisions in December 2025

Sources