510(k) · Cleared
ClearedTwinheads TH-101 Extracorporeal Shock Wave Lithotripter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fmd, LLC · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on May 2, 2003 as substantially equivalent to K003529 (Edap Technomed, Inc., 2001) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- May 2, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003529 (2001). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK003529 Sonolith Praktis, Endourology Table PraktisEdap Technomed, Inc. · 2001
- This deviceK030346 Twinheads TH-101 Extracorporeal Shock Wave LithotripterFmd, LLC · 2003
- Descendant · cites it directly · 0 of its ownK111808 Sonolith I-MoveEdap Tms France · 2011
- Descendant · cites it directly · 0 of its ownK050091 Tripter-X1 Compact Duet SP (Separated Pulse)Direx Systems Corp. · 2005
- Descendant · cites it directly · 0 of its ownK042561 Twinheads TH-103 Extracorporeal Shock Wave LithotripterFmd, LLC · 2004
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003529 | Sonolith Praktis, Endourology Table Praktis | Edap Technomed, Inc. | 2001 | — |
| 0 (this device) | K030346 | Twinheads TH-101 Extracorporeal Shock Wave Lithotripter | Fmd, LLC | 2003 | — |
| +1 | K111808 | Sonolith I-Move | Edap Tms France | 2011 | — |
| +1 | K050091 | Tripter-X1 Compact Duet SP (Separated Pulse) | Direx Systems Corp. | 2005 | — |
| +1 | K042561 | Twinheads TH-103 Extracorporeal Shock Wave Lithotripter | Fmd, LLC | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K003529 | Sonolith Praktis, Endourology Table PraktisSummary page 1…alence The Twinheads0 TH-101 ESWL is substantially equivalent to the following legally .. marketed devices: EDAP Technomed, Inc. - Sonolith Praktis (K003529) PCK Electronic Industry and Trade Co., Inc. - Stonelith V5 (KO1 11106) 4. Device description The TwinheadsB TH-101… | 2001 |
| * | K011106 | Stonelith, Model V5 | 2002 |
What descends from it? (3)
3 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?
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 TwinheadsO TH-10 1 Extracorporeal Shock Wave Lithotripter is intended to
fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter
(upper, middle, and lower ureter).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030346 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030346: Twinheads TH-101 Extracorporeal Shock Wave Lithotripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030346
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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