510(k) · Cleared
ClearedStorz Modulith, Model SLX-F2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Aug 26, 2004 after a 184-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Aug 26, 2004
- Review
- 184 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK040476 Storz Modulith, Model SLX-F2KARL STORZ Endoscopy-America, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK101482 EM-9000Elite Medical, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK072788 Storz Modulith Lithotripter SLX-F2-F180KARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK251562 OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025
- Descendant · 2 generations on · 0 of its ownK201001 Modulith SLX-F2Karl Storz Endoscopy America · 2021
- Descendant · 2 generations on · 0 of its ownK131721 Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1Comed Medical Systems Co., Ltd. · 2014
Most influential descendants
Showing 5 of 5 · See all- K101482EM-9000Elite Medical, Inc. · 2011 · cites it directly2descendants
- K072788Storz Modulith Lithotripter SLX-F2-F180KARL STORZ Endoscopy-America, Inc. · 2007 · cites it directly1descendant
- K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025 · 2 generations on0descendants
- K201001Modulith SLX-F2Karl Storz Endoscopy America · 2021 · 2 generations on0descendants
- K131721Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1Comed Medical Systems Co., Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040476 | Storz Modulith, Model SLX-F2 | KARL STORZ Endoscopy-America, Inc. | 2004 | — |
| +1 | K101482 | EM-9000 | Elite Medical, Inc. | 2011 | — |
| +1 | K072788 | Storz Modulith Lithotripter SLX-F2-F180 | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +2 | K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | 2025 | — |
| +2 | K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | 2021 | — |
| +2 | K131721 | Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1 | Comed Medical Systems Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | — | Storz Modulith® Lithotripter Model SLX Named without a submission 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, K101482 (Elite Medical, Inc., 2011) 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?
The Storz Medical MODULITH® Model SLX F2 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/K040476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040476: Storz Modulith, Model SLX-F2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040476
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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