510(k) · Cleared
ClearedStorz Modulith Lithotripter SLX-F2-F180
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 Dec 26, 2007 as substantially equivalent to K040476 (KARL STORZ Endoscopy-America, Inc., 2004) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Dec 26, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P970019 (1997). 6 ancestors in all, the oldest P840008 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP970019 Healthtronics Lithotron Lihtotripsy SystemHealthtronics Surgical Services, Inc. · 1997
- 2 generations backK040461 Econolith E3000, Model 3000 (SW-6)Medispec, Ltd. · 2004
- 1 generation backK063504 Econolith EM1000Medispec, Ltd. · 2007
- This deviceK072788 Storz Modulith Lithotripter SLX-F2-F180KARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK201001 Modulith SLX-F2Karl Storz Endoscopy America · 2021
Most influential descendants
Showing 1 of 1 · See all- K201001Modulith SLX-F2Karl Storz Endoscopy America · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P970019 | Healthtronics Lithotron Lihtotripsy System | Healthtronics Surgical Services, Inc. | 1997 | — |
| −2 | K040461 | Econolith E3000, Model 3000 (SW-6) | Medispec, Ltd. | 2004 | — |
| −1 | K063504 | Econolith EM1000 | Medispec, Ltd. | 2007 | — |
| 0 (this device) | K072788 | Storz Modulith Lithotripter SLX-F2-F180 | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +1 | 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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K040476 | Storz Modulith, Model SLX-F2Summary page 1…ter, Extracorporeal Shock-Wave. Urological Regulation Number: 21 CFR 876.5990 Product Code: LNS Predicate Device(s): Storz MODULITH Lithotripter SLX-F2 (K(040476) Medispec Econolith EM 1000 (K(063504) Device Description: The Storz MODULITH® Lithotripter SLX-F2 F180… | 2004 |
| * | K063504 | Econolith EM1000Summary page 1…21 CFR 876.5990 Product Code: LNS Predicate Device(s): Storz MODULITH Lithotripter SLX-F2 (K(040476) Medispec Econolith EM 1000 (K(063504) Device Description: The Storz MODULITH® Lithotripter SLX-F2 F180 is an Extracorporeal Shock Wave Litho… | 2007 |
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 |
|---|---|---|---|
| K201001 | Modulith SLX-F2 | 2021 | 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 10 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K201001 (Karl Storz Endoscopy America, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040476.
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. 2007, 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 MODULITH® Lithotripter SLX-F2 F180 is intended 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/K072788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072788: Storz Modulith Lithotripter SLX-F2-F180.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072788
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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