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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 / January 2026 / K252913

510(k) cleared

Break Wave

Sonomotion, Inc. · Jan 12, 2026 · K252913

FDA cleared the Break Wave from Sonomotion, Inc. on Jan 12, 2026 under K252913, a traditional 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 Sep 12, 2025. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sonomotion, Inc. has 2 other decisions in the tracker over the last 12 months: K262200 (Stone Clear (BWSC-LP9-02)), K261086 (Break Wave).

Questions & Answers

What did FDA clear under K252913?

K252913 is the FDA 510(k) for Break Wave, submitted by Sonomotion, Inc.. FDA's decision date was Jan 12, 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 K252913.

How long did the K252913 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on Jan 12, 2026, 122 days later.

← All decisions in January 2026

Sources