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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 / K253122

510(k) cleared

Sim&Size

Sim&Cure · Dec 23, 2025 · K253122

FDA cleared the Sim&Size from Sim&Cure on Dec 23, 2025 under K253122, a traditional 510(k). The device falls under product code PZO, Software For Visualization Of Vascular Anatomy And Intravascular Devices, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 25, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Sim&Cure in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253122?

K253122 is the FDA 510(k) for Sim&Size, submitted by Sim&Cure. FDA's decision date was Dec 23, 2025, under product code PZO (Software For Visualization Of Vascular Anatomy And Intravascular Devices).

Who makes the Sim&Size?

Sim&Cure, based in Montpellier, is the applicant of record for K253122.

How long did the K253122 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Dec 23, 2025, 89 days later.

← All decisions in December 2025