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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 / June 2026 / K260190

510(k) cleared

ARTHUR

ROPCA ApS · Jun 18, 2026 · K260190

FDA cleared the ARTHUR from ROPCA ApS on Jun 18, 2026 under K260190, a traditional 510(k). The device falls under product code IYO, System, Imaging, Pulsed Echo, Ultrasonic, regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 22, 2026. The decision came 147 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ROPCA ApS has one other decision in the tracker over the last 12 months: K260192 (DIANA).

Questions & Answers

What did FDA clear under K260190?

K260190 is the FDA 510(k) for ARTHUR, submitted by ROPCA ApS. FDA's decision date was Jun 18, 2026, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the ARTHUR?

ROPCA ApS, based in Odense M, is the applicant of record for K260190.

How long did the K260190 review take?

FDA received the submission on Jan 22, 2026 and issued its decision on Jun 18, 2026, 147 days later.

← All decisions in June 2026