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THE TAPE

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 / September 2025 / K251022

510(k) cleared

3D-SHAPER

3D-Shaper Medical S.L · Sep 5, 2025 · K251022

FDA cleared the 3D-SHAPER from 3D-Shaper Medical S.L on Sep 5, 2025 under K251022, a traditional 510(k). The device falls under product code KGI, Densitometer, Bone, regulated at 21 CFR 892.1170 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 2, 2025. The decision came 156 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for 3D-Shaper Medical S.L in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251022?

K251022 is the FDA 510(k) for 3D-SHAPER, submitted by 3D-Shaper Medical S.L. FDA's decision date was Sep 5, 2025, under product code KGI (Densitometer, Bone).

Who makes the 3D-SHAPER?

3D-Shaper Medical S.L, based in Barcelona, is the applicant of record for K251022.

How long did the K251022 review take?

FDA received the submission on Apr 2, 2025 and issued its decision on Sep 5, 2025, 156 days later.

← All decisions in September 2025