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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 / March 2026 / K252099

510(k) cleared

Trinias

Shimadzu Corporation · Mar 24, 2026 · K252099

FDA cleared the Trinias from Shimadzu Corporation on Mar 24, 2026 under K252099, a abbreviated 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 3, 2025. The decision came 264 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 Shimadzu Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252099?

K252099 is the FDA 510(k) for Trinias, submitted by Shimadzu Corporation. FDA's decision date was Mar 24, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the Trinias?

Shimadzu Corporation, based in Kyoto, is the applicant of record for K252099.

How long did the K252099 review take?

FDA received the submission on Jul 3, 2025 and issued its decision on Mar 24, 2026, 264 days later.

← All decisions in March 2026