# K252913: Break Wave

- Pathway: 510(k) (Traditional)
- Applicant: Sonomotion, Inc.
- Decided: Jan 12, 2026 after 122 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to P840008 (1984). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072538: Piezolith 3000 Triple-Focus Lithotripter, United Medical Systems, Inc. (2008) Summary page 5.

## Most influential descendants
- K261086: Break Wave (2026), 0 descendants of its own

## Indications for use
The Break Wave device is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper and lower ureter).

Source page: https://510kreport.com/device/K252913
Methodology: https://510kreport.com/methodology