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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 / July 2026 / K253452

510(k) cleared

Accuro 3S

Rivanna Medical, Inc. · Jul 24, 2026 · K253452

FDA cleared the Accuro 3S from Rivanna Medical, Inc. on Jul 24, 2026 under K253452, 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 Oct 6, 2025. The decision came 291 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: K261014 (Accuro® 3S Needle Guide Kit), K254021 (Accuro XV).

Questions & Answers

What did FDA clear under K253452?

K253452 is the FDA 510(k) for Accuro 3S, submitted by Rivanna Medical, Inc.. FDA's decision date was Jul 24, 2026, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the Accuro 3S?

Rivanna Medical, Inc., based in Charlottesville, VA, is the applicant of record for K253452.

How long did the K253452 review take?

FDA received the submission on Oct 6, 2025 and issued its decision on Jul 24, 2026, 291 days later.

← All decisions in July 2026

Sources