K252913 is an FDA 510(k) clearance for the Break Wave. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.
Submitted by Sonomotion, Inc. (San Mateo, US). The FDA issued a Cleared decision on January 12, 2026 after a review of 122 days - within the typical 510(k) review window.
This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5990 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.
View all Sonomotion, Inc. devices
NCT05701098
Completed
Interventional
Industry-sponsored
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
Pivotal Study of the SonoMotion Break Wave™ (Trade Mark) System for the Comminution of Urinary Tract Stones
| Condition studied |
Kidney Stone; Urolithiasis; Nephrolithiasis; Renal Calculi; Kidney Calculi; Nephrolith; Urinary Calculi |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Sponsor |
SonoMotion
(industry)
|
Started 2023-10-09
→
Primary completion 2025-06-18
→
Completed 2025-07-31
Primary outcome
Primary Effectiveness Endpoint
Secondary outcome
Secondary safety endpoint
Study completed - no results published.
This trial concluded in 2025 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov