510(k) · Cleared
ClearedExtra Corporeal Shockwave Lithotripter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier Medtech Systems · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on May 14, 2013 as substantially equivalent to K121656 (Dornier Medtech America, Inc., 2012) and 1 other predicate after a 57-day review. Its family tree reaches back 10 generations to 1980.
- Decided
- May 14, 2013
- Review
- 57 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K801623 (1980). 64 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 6 generations between
- 3 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- 1 generation backK122768 GenesisDornier Medtech America, Inc. · 2013
- This deviceK130729 Extra Corporeal Shockwave LithotripterDornier Medtech Systems · 2013
Show all 10 generations
- Root · 10 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 9 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 8 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 7 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 6 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 5 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- 1 generation backK122768 GenesisDornier Medtech America, Inc. · 2013
- This deviceK130729 Extra Corporeal Shockwave LithotripterDornier Medtech Systems · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −9 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −8 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −7 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −6 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −5 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −4 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −3 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −2 | K101491 | Uroskop Omnia | Siemens Medical Solutions USA, Inc. | 2010 | 12 |
| −1 | K122768 | Genesis | Dornier Medtech America, Inc. | 2013 | — |
| 0 (this device) | K130729 | Extra Corporeal Shockwave Lithotripter | Dornier Medtech Systems | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 13 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2004 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K121656 | Gemini LithotripterSummary page 1…oreal shock wave lithotripters as Class 11devices with special controls. The Product Code for these lithotripters is LNS. Predicate Devices Dornier Gemini Lithotripter (K 121656) Dornier Genesis (K 122768) FPD system Purpose of the Special 510(k) Notice The Gemini FPD is a modification to Dornier's Gemini… | 2012 |
| * | K122768 | GenesisSummary page 1…ers as Class 11devices with special controls. The Product Code for these lithotripters is LNS. Predicate Devices Dornier Gemini Lithotripter (K 121656) Dornier Genesis (K 122768) FPD system Purpose of the Special 510(k) Notice The Gemini FPD is a modification to Dornier's Gemini Lithotripter (K 12 1656).… | 2013 |
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 33 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 20 of the 64 ancestors have a recall of any class.
- 2 other devices also cite its predicate K121656.
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. 2013, 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 Gemini FPD is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130729: Extra Corporeal Shockwave Lithotripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130729
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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