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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 / K261086

510(k) cleared

Break Wave

Sonomotion, Inc. · Apr 29, 2026 · K261086

FDA cleared the Break Wave from Sonomotion, Inc. on Apr 29, 2026 under K261086, a special 510(k). The device falls under product code LNS, Lithotriptor, Extracorporeal Shock-Wave, Urological, regulated at 21 CFR 876.5990 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 1, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Sonomotion, Inc. has 2 other decisions in the tracker over the last 12 months: K262200 (Stone Clear (BWSC-LP9-02)), K252913 (Break Wave).

Questions & Answers

What did FDA clear under K261086?

K261086 is the FDA 510(k) for Break Wave, submitted by Sonomotion, Inc.. FDA's decision date was Apr 29, 2026, under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological).

Who makes the Break Wave?

Sonomotion, Inc., based in San Mateo, CA, is the applicant of record for K261086.

How long did the K261086 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Apr 29, 2026, 28 days later.

← All decisions in April 2026

Sources