510(k) · Cleared
ClearedTripter 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 Jan 17, 2003 as substantially equivalent to P920034 (Medirex, Inc., 1996) and 3 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1995. 10 later devices descend from it.
- Decided
- Jan 17, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to P920051 (1995). 4 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 1 generation backP920051 Storz Modulith (TM) LithotripterKARL STORZ Endoscopy-America, Inc. · 1995
- This deviceK023535 Tripter X-1 Compact DuetDirex Systems Corp. · 2003
- Descendant · cites it directly · 9 of its ownK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
- Descendant · cites it directly · 8 of its ownK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
- Descendant · 2 generations on · 6 of its ownK053640 IntegraDirex Systems Corp. · 2006
- Descendant · 2 generations on · 3 of its ownK062147 Integra SLDirex Systems Corp. · 2006
- Descendant · 3 generations on · 2 of its ownK072538 Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K040470Tripter X-1 CompactDirex Systems Corp. · 2004 · cites it directly9descendants
- K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004 · cites it directly8descendants
- K053640IntegraDirex Systems Corp. · 2006 · 2 generations on6descendants
- K062147Integra SLDirex Systems Corp. · 2006 · 2 generations on3descendants
- K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P920051 | Storz Modulith (TM) Lithotripter | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| 0 (this device) | K023535 | Tripter X-1 Compact Duet | Direx Systems Corp. | 2003 | — |
| +1 | K040470 | Tripter X-1 Compact | Direx Systems Corp. | 2004 | — |
| +1 | K041582 | Modification to Tripter X-1 Compact Duet | Direx Systems Corp. | 2004 | — |
| +2 | K053640 | Integra | Direx Systems Corp. | 2006 | — |
| +2 | K062147 | Integra SL | Direx Systems Corp. | 2006 | — |
| +3 | K072538 | Piezolith 3000 Triple-Focus Lithotripter | United Medical Systems, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | P920034 | Tripter-X1 NovaSummary page 1…roduct code: 78 LNS Regulatory Class: Class II Regulation Number: 21 CFR 876.5990 3. Predicate Devices Tripter X-1 Compact: P920034 Storz Modulith SL-20/ (SLX): P920051 Storz SLK: KO10340 PCK Stonelith V5: KO11106… | 1996 |
| * | P920051 | Storz Modulith (TM) LithotripterSummary page 1…Class II Regulation Number: 21 CFR 876.5990 3. Predicate Devices Tripter X-1 Compact: P920034 Storz Modulith SL-20/ (SLX): P920051 Storz SLK: KO10340 PCK Stonelith V5: KO11106 6-1 4. Intended Use: F… | 1995 |
| * | K010340 | Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral… | 2001 |
| * | K011106 | Stonelith, Model V5 | 2002 |
What descends from it? (10)
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?
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 Tripter-X1 Compact Duet Extracorporeal Shock Wave Lithotripter is indicated for use in 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/K023535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023535: 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/K023535
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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