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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 / May 2026 / K252784

510(k) cleared

eXaSkin Plus

Anatomical Geometry S.L. · May 22, 2026 · K252784

FDA cleared the eXaSkin Plus from Anatomical Geometry S.L. on May 22, 2026 under K252784, a traditional 510(k). The device falls under product code MUJ, System, Planning, Radiation Therapy Treatment, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 2, 2025. The decision came 262 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 Anatomical Geometry S.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252784?

K252784 is the FDA 510(k) for eXaSkin Plus, submitted by Anatomical Geometry S.L.. FDA's decision date was May 22, 2026, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the eXaSkin Plus?

Anatomical Geometry S.L., based in Mairena Del Aljarafe, is the applicant of record for K252784.

How long did the K252784 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on May 22, 2026, 262 days later.

← All decisions in May 2026