510(k) · Cleared
ClearedModification to Tripter X-1 Compact Duet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Direx Systems Corp. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Jul 7, 2004 as substantially equivalent to K023535 (Direx Systems Corp., 2003) and 1 other predicate after a 23-day review. Its family tree reaches back 3 generations to 1984. 8 later devices descend from it.
- Decided
- Jul 7, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P840008 (1984). 12 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 3 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- 2 generations backK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
- 1 generation backK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
- This deviceK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
- Descendant · cites it directly · 6 of its ownK053640 IntegraDirex Systems Corp. · 2006
- Descendant · cites it directly · 3 of its ownK062147 Integra SLDirex Systems Corp. · 2006
- Descendant · 2 generations on · 2 of its ownK072538 Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK252913 Break WaveSonomotion, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK261086 Break WaveSonomotion, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K053640IntegraDirex Systems Corp. · 2006 · cites it directly6descendants
- K062147Integra SLDirex Systems Corp. · 2006 · cites it directly3descendants
- K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008 · 2 generations on2descendants
- K252913Break WaveSonomotion, Inc. · 2026 · 3 generations on1descendant
- K261086Break WaveSonomotion, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | Dornier Medtech America, Inc. | 1984 | — |
| −2 | K011873 | Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) | Dornier | 2001 | — |
| −1 | K040470 | Tripter X-1 Compact | Direx Systems Corp. | 2004 | — |
| 0 (this device) | K041582 | Modification to Tripter X-1 Compact Duet | Direx Systems Corp. | 2004 | — |
| +1 | K053640 | Integra | Direx Systems Corp. | 2006 | — |
| +1 | K062147 | Integra SL | Direx Systems Corp. | 2006 | — |
| +2 | K072538 | Piezolith 3000 Triple-Focus Lithotripter | United Medical Systems, Inc. | 2008 | — |
| +3 | K252913 | Break Wave | Sonomotion, Inc. | 2026 | — |
| +4 | K261086 | Break Wave | Sonomotion, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K023535 | Tripter X-1 Compact DuetSummary page 1…78 LNS Regulatory Class: Class II Regulation Number: 21 CFR 876.5990 3. Predicate Devices Tripter X1 Compact Duet: K023535 Tripter X1 Compact: K040470 A-1 4. Intended Use: The intended use… | 2003 |
| * | K040470 | Tripter X-1 CompactSummary page 1…Class II Regulation Number: 21 CFR 876.5990 3. Predicate Devices Tripter X1 Compact Duet: K023535 Tripter X1 Compact: K040470 A-1 4. Intended Use: The intended use of the Tripter-X1 Duet Extracor… | 2004 |
What descends from it? (8)
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K053640 (Direx Systems Corp., 2006) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K023535.
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 intended use of the Tripter-X1 Compact Duet Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041582: Modification to Tripter X-1 Compact Duet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041582
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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