510(k) · Cleared
ClearedBreak Wave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonomotion, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Jan 12, 2026 as substantially equivalent to K072538 (United Medical Systems, Inc., 2008) after a 122-day review. Its family tree reaches back 7 generations to 1984. 1 later device descends from it.
- Decided
- Jan 12, 2026
- Review
- 122 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to P840008 (1984). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- 6 generations backK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
- 5 generations backK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
- 4 generations backK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
- 3 generations backK053640 IntegraDirex Systems Corp. · 2006
- 2 generations backK062147 Integra SLDirex Systems Corp. · 2006
- 1 generation backK072538 Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008
- This deviceK252913 Break WaveSonomotion, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK261086 Break WaveSonomotion, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261086Break WaveSonomotion, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | Dornier Medtech America, Inc. | 1984 | — |
| −6 | K011873 | Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) | Dornier | 2001 | — |
| −5 | K040470 | Tripter X-1 Compact | Direx Systems Corp. | 2004 | — |
| −4 | K041582 | Modification to Tripter X-1 Compact Duet | Direx Systems Corp. | 2004 | — |
| −3 | K053640 | Integra | Direx Systems Corp. | 2006 | — |
| −2 | K062147 | Integra SL | Direx Systems Corp. | 2006 | — |
| −1 | K072538 | Piezolith 3000 Triple-Focus Lithotripter | United Medical Systems, Inc. | 2008 | — |
| 0 (this device) | K252913 | Break Wave | Sonomotion, Inc. | 2026 | — |
| +1 | K261086 | Break Wave | Sonomotion, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNS device
- #1 K261086 Break Wavescore 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072538 | Piezolith 3000 Triple-Focus LithotripterSummary page 5…astroenterology/Urology 3. PREDICATE DEVICE The Break Wave device is substantially equivalent to the Piezolith 3000 Triple-focus extracorporeal lithotripter (K072538, Product Code: LNS). 4. DEVICE DESCRIPTION The Break Wave device is designed for the extracorporeal fragmentation of calculi… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261086 | Break Wave | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K261086 (Sonomotion, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LNS devicesLNS Lithotriptor, Extracorporeal Shock-Wave, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LNS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNS
111in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNS
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LNS
61in 2025
MAUDE reports naming product code LNS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 146 | 0 | 4 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 3 | 307 | 0 | 21 |
| 2012 | 3 | 111 | 0 | 20 |
| 2013 | 2 | — | 0 | 18 |
| 2014 | 2 | — | 0 | 21 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 0 | — | 0 | 50 |
| 2017 | 2 | — | 0 | 54 |
| 2018 | 0 | — | 0 | 59 |
| 2019 | 0 | — | 0 | 60 |
| 2020 | 1 | — | 0 | 38 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 52 |
| 2023 | 2 | — | 0 | 86 |
| 2024 | 0 | — | 0 | 40 |
| 2025 | 1 | — | 0 | 61 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Break Wave device is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper and lower ureter).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252913: Break Wave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252913
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026