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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 / K252433

510(k) cleared

Sonio Detect (v3)

Sonio · Mar 16, 2026 · K252433

FDA cleared the Sonio Detect (v3) from Sonio on Mar 16, 2026 under K252433, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 1, 2025. The decision came 227 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sonio has one other decision in the tracker over the last 12 months: K261519 (Sonio Suspect).

Questions & Answers

What did FDA clear under K252433?

K252433 is the FDA 510(k) for Sonio Detect (v3), submitted by Sonio. FDA's decision date was Mar 16, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Sonio Detect (v3)?

Sonio, based in Paris, is the applicant of record for K252433.

How long did the K252433 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Mar 16, 2026, 227 days later.

← All decisions in March 2026