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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 / K254021

510(k) cleared

Accuro XV

Rivanna Medical, Inc. · Apr 9, 2026 · K254021

FDA cleared the Accuro XV from Rivanna Medical, Inc. on Apr 9, 2026 under K254021, 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 Dec 16, 2025. The decision came 114 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Rivanna Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K253452 (Accuro 3S), K261014 (Accuro® 3S Needle Guide Kit).

Questions & Answers

What did FDA clear under K254021?

K254021 is the FDA 510(k) for Accuro XV, submitted by Rivanna Medical, Inc.. FDA's decision date was Apr 9, 2026, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the Accuro XV?

Rivanna Medical, Inc., based in Charlottesville, VA, is the applicant of record for K254021.

How long did the K254021 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Apr 9, 2026, 114 days later.

← All decisions in April 2026

Sources