# K261086: Break Wave

- Pathway: 510(k) (Special)
- Applicant: Sonomotion, Inc.
- Decided: Apr 29, 2026 after 28 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: 8 generations back to P840008 (1984). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252913: Break Wave, Sonomotion, Inc. (2026) Summary page 5.

## 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/K261086
Methodology: https://510kreport.com/methodology