510(k) · Cleared
ClearedModulith SLK Lithotripter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Aug 16, 2002 after a 441-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Aug 16, 2002
- Review
- 441 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK011700 Modulith SLK LithotripterKarl Storz Endoscopy · 2002
- Descendant · cites it directly · 2 of its ownK072538 Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK252913 Break WaveSonomotion, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK120769 Modulth SLKKARL STORZ Endoscopy-America, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK261086 Break WaveSonomotion, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK213772 LM-9300 Plus LithotripterLite-Med, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008 · cites it directly2descendants
- K252913Break WaveSonomotion, Inc. · 2026 · 2 generations on1descendant
- K120769Modulth SLKKARL STORZ Endoscopy-America, Inc. · 2012 · cites it directly1descendant
- K261086Break WaveSonomotion, Inc. · 2026 · 3 generations on0descendants
- K213772LM-9300 Plus LithotripterLite-Med, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011700 | Modulith SLK Lithotripter | Karl Storz Endoscopy | 2002 | — |
| +1 | K072538 | Piezolith 3000 Triple-Focus Lithotripter | United Medical Systems, Inc. | 2008 | — |
| +2 | K252913 | Break Wave | Sonomotion, Inc. | 2026 | — |
| +1 | K120769 | Modulth SLK | KARL STORZ Endoscopy-America, Inc. | 2012 | — |
| +3 | K261086 | Break Wave | Sonomotion, Inc. | 2026 | — |
| +2 | K213772 | LM-9300 Plus Lithotripter | Lite-Med, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 K252913 Break Wavescore 15.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K072538 (United Medical Systems, Inc., 2008) has gone furthest, with 2 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.
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?
Storz Modulith@Lithotripter Model SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K011700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011700: Modulith SLK Lithotripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011700
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026