510(k) · Cleared
ClearedModulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral Calculi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Lithotripsy-America, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Feb 13, 2001 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Feb 13, 2001
- Review
- 8 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK010340 Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and…Karl Storz Lithotripsy-America, Inc. · 2001
- Descendant · cites it directly · 10 of its ownK023535 Tripter X-1 Compact DuetDirex Systems Corp. · 2003
- Descendant · 2 generations on · 9 of its ownK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
- Descendant · 2 generations on · 8 of its ownK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
- Descendant · cites it directly · 6 of its ownK053640 IntegraDirex Systems Corp. · 2006
- Descendant · 2 generations on · 3 of its ownK062147 Integra SLDirex Systems Corp. · 2006
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K023535Tripter X-1 Compact DuetDirex Systems Corp. · 2003 · cites it directly10descendants
- K040470Tripter X-1 CompactDirex Systems Corp. · 2004 · 2 generations on9descendants
- K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004 · 2 generations on8descendants
- K053640IntegraDirex Systems Corp. · 2006 · cites it directly6descendants
- K062147Integra SLDirex Systems Corp. · 2006 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010340 | Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper… | Karl Storz Lithotripsy-America, Inc. | 2001 | — |
| +1 | K023535 | Tripter X-1 Compact Duet | Direx Systems Corp. | 2003 | — |
| +2 | K040470 | Tripter X-1 Compact | Direx Systems Corp. | 2004 | — |
| +2 | K041582 | Modification to Tripter X-1 Compact Duet | Direx Systems Corp. | 2004 | — |
| +1 | K053640 | Integra | Direx Systems Corp. | 2006 | — |
| +2 | K062147 | Integra SL | Direx Systems Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 124 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, K023535 (Direx Systems Corp., 2003) has gone furthest, with 10 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 | — |
https://510kreport.com/device/K010340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010340: Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral Calculi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010340
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026