510(k) · Cleared
ClearedModulith SLX-F2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy America · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Mar 30, 2021 as substantially equivalent to K072788 (KARL STORZ Endoscopy-America, Inc., 2007) and 1 other predicate after a 348-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Mar 30, 2021
- Review
- 348 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to P970019 (1997). 11 ancestors in all, the oldest P840008 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backP970019 Healthtronics Lithotron Lihtotripsy SystemHealthtronics Surgical Services, Inc. · 1997
- 4 generations backK040461 Econolith E3000, Model 3000 (SW-6)Medispec, Ltd. · 2004
- 3 generations backK063504 Econolith EM1000Medispec, Ltd. · 2007
- 2 generations backK103217 Lite-Med LM-9200 ElmaLite-Med, Inc. · 2011
- 1 generation backK142561 LM-9300 ELMA LithotripterLite-Med, Inc. · 2015
- This deviceK201001 Modulith SLX-F2Karl Storz Endoscopy America · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P970019 | Healthtronics Lithotron Lihtotripsy System | Healthtronics Surgical Services, Inc. | 1997 | — |
| −4 | K040461 | Econolith E3000, Model 3000 (SW-6) | Medispec, Ltd. | 2004 | — |
| −3 | K063504 | Econolith EM1000 | Medispec, Ltd. | 2007 | — |
| −2 | K103217 | Lite-Med LM-9200 Elma | Lite-Med, Inc. | 2011 | — |
| −1 | K142561 | LM-9300 ELMA Lithotripter | Lite-Med, Inc. | 2015 | — |
| 0 (this device) | K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K072788 | Storz Modulith Lithotripter SLX-F2-F180Summary page 4…me: Extracorporeal shock wave lithotripter Product Code: LNS Regulation: 21 CFR 876.5990 Predicate Device(s): Modulith SLX-F2 180 (K072788) – Primary LM-9300 ELMA (K142561) - Secondary **The above reference device have… | 2007 |
| * | K142561 | LM-9300 ELMA LithotripterSummary page 4…t Code: LNS Regulation: 21 CFR 876.5990 Predicate Device(s): Modulith SLX-F2 180 (K072788) – Primary LM-9300 ELMA (K142561) - Secondary **The above reference device have not been subject to any recall**… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 11 ancestors has a recall.
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. 2021, 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 STORZ MEDICAL Lithotripter Model MODULITH® SLX-F2 is indicated for the use in the noninvasive fragmentation of calculi in the kidney, in upper, middle and lower ureter for all adults and children 3 years or over.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201001: Modulith 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/K201001
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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