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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 / April 2026 / K252663

510(k) cleared

Inbentus Versatile

Iconic Solutions by Murcia, SL · Apr 14, 2026 · K252663

FDA cleared the Inbentus Versatile from Iconic Solutions by Murcia, SL on Apr 14, 2026 under K252663, a traditional 510(k). The device falls under product code CBK, Ventilator, Continuous, Facility Use, regulated at 21 CFR 868.5895 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Aug 22, 2025. The decision came 235 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 Iconic Solutions by Murcia, SL in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252663?

K252663 is the FDA 510(k) for Inbentus Versatile, submitted by Iconic Solutions by Murcia, SL. FDA's decision date was Apr 14, 2026, under product code CBK (Ventilator, Continuous, Facility Use).

Who makes the Inbentus Versatile?

Iconic Solutions by Murcia, SL, based in Murcia, is the applicant of record for K252663.

How long did the K252663 review take?

FDA received the submission on Aug 22, 2025 and issued its decision on Apr 14, 2026, 235 days later.

← All decisions in April 2026