510(k) · Cleared
ClearedSonolith Praktis, Endourology Table Praktis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edap Technomed, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Feb 12, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Feb 12, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK003529 Sonolith Praktis, Endourology Table PraktisEdap Technomed, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK030346 Twinheads TH-101 Extracorporeal Shock Wave LithotripterFmd, LLC · 2003
- Descendant · cites it directly · 1 of its ownK083614 Sonolith I-Sys LithotriperTechnomed Medical Systems, SA · 2009
- Descendant · cites it directly · 0 of its ownK111808 Sonolith I-MoveEdap Tms France · 2011
- Descendant · 2 generations on · 0 of its ownK050091 Tripter-X1 Compact Duet SP (Separated Pulse)Direx Systems Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK042561 Twinheads TH-103 Extracorporeal Shock Wave LithotripterFmd, LLC · 2004
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030346Twinheads TH-101 Extracorporeal Shock Wave LithotripterFmd, LLC · 2003 · cites it directly3descendants
- K083614Sonolith I-Sys LithotriperTechnomed Medical Systems, SA · 2009 · cites it directly1descendant
- K111808Sonolith I-MoveEdap Tms France · 2011 · cites it directly0descendants
- K050091Tripter-X1 Compact Duet SP (Separated Pulse)Direx Systems Corp. · 2005 · 2 generations on0descendants
- K042561Twinheads TH-103 Extracorporeal Shock Wave LithotripterFmd, LLC · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003529 | Sonolith Praktis, Endourology Table Praktis | Edap Technomed, Inc. | 2001 | — |
| +1 | K030346 | Twinheads TH-101 Extracorporeal Shock Wave Lithotripter | Fmd, LLC | 2003 | — |
| +1 | K083614 | Sonolith I-Sys Lithotriper | Technomed Medical Systems, SA | 2009 | — |
| +1 | K111808 | Sonolith I-Move | Edap Tms France | 2011 | — |
| +2 | K050091 | Tripter-X1 Compact Duet SP (Separated Pulse) | Direx Systems Corp. | 2005 | — |
| +2 | K042561 | Twinheads TH-103 Extracorporeal Shock Wave Lithotripter | Fmd, LLC | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
4 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, K030346 (Fmd, LLC, 2003) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K003529 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003529: Sonolith Praktis, Endourology Table Praktis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003529
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026