510(k) · Cleared
ClearedTripter X-1 Compact
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 Apr 28, 2004 as substantially equivalent to P920034 (Medirex, Inc., 1996) and 6 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1984. 9 later devices descend from it.
- Decided
- Apr 28, 2004
- Review
- 64 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to P840008 (1984). 11 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- 1 generation backK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
- This deviceK040470 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
- Descendant · 4 generations on · 1 of its ownK252913 Break WaveSonomotion, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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
- K252913Break WaveSonomotion, Inc. · 2026 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | Dornier Medtech America, Inc. | 1984 | — |
| −1 | K011873 | Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) | Dornier | 2001 | — |
| 0 (this device) | 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 | — |
| +4 | K252913 | 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 |
|---|---|---|
| 2004 | 1 | 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? (7)
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…Class II Regulation Number: 21 CFR 876.5990 3. Predicate Devices Tripter-X1 Series Lithotripters (Tripter-X1 and Tripter -X1 Compact): P- 920034 Tripter X1 Compact Duet: K023535 Ipu Rx-2 Image processing unit, Radiology K964327 Dornier Compacts / Compact Delta: P84… | 1996 |
| * | K023535 | Tripter X-1 Compact DuetSummary page 1…21 CFR 876.5990 3. Predicate Devices Tripter-X1 Series Lithotripters (Tripter-X1 and Tripter -X1 Compact): P- 920034 Tripter X1 Compact Duet: K023535 Ipu Rx-2 Image processing unit, Radiology K964327 Dornier Compacts / Compact Delta: P840008/S56 Dornier Compact Alpha: K… | 2003 |
| * | K964327 | IPU RX-2Summary page 1…es Tripter-X1 Series Lithotripters (Tripter-X1 and Tripter -X1 Compact): P- 920034 Tripter X1 Compact Duet: K023535 Ipu Rx-2 Image processing unit, Radiology K964327 Dornier Compacts / Compact Delta: P840008/S56 Dornier Compact Alpha: K002929 (and K01 1873) SONOLITH 3000 PMA: P880011… | 1997 |
| * | P840008 | Dornier Lithotripter Compact Transportable (DLCT)Summary page 1…r-X1 and Tripter -X1 Compact): P- 920034 Tripter X1 Compact Duet: K023535 Ipu Rx-2 Image processing unit, Radiology K964327 Dornier Compacts / Compact Delta: P840008/S56 Dornier Compact Alpha: K002929 (and K01 1873) SONOLITH 3000 PMA: P880011 6-1… | 1984 |
| * | K002929 | Dornier Compact Alpha LithotripterSummary page 1…20034 Tripter X1 Compact Duet: K023535 Ipu Rx-2 Image processing unit, Radiology K964327 Dornier Compacts / Compact Delta: P840008/S56 Dornier Compact Alpha: K002929 (and K01 1873) SONOLITH 3000 PMA: P880011 6-1 4. Intended Use: The in… | 2001 |
| * | K011873 | Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP)Summary page 1…ter X1 Compact Duet: K023535 Ipu Rx-2 Image processing unit, Radiology K964327 Dornier Compacts / Compact Delta: P840008/S56 Dornier Compact Alpha: K002929 (and K01 1873) SONOLITH 3000 PMA: P880011 6-1 4. Intended Use: The intended use of… | 2001 |
| * | P880011 | Technomed International Sonolith 2000Summary page 1…Ipu Rx-2 Image processing unit, Radiology K964327 Dornier Compacts / Compact Delta: P840008/S56 Dornier Compact Alpha: K002929 (and K01 1873) SONOLITH 3000 PMA: P880011 6-1 4. Intended Use: The intended use of the Tripter-X1 Compact Extracor… | 1989 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041582 | Modification to Tripter X-1 Compact Duet | 2004 | 8 |
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 16.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K041582 (Direx Systems Corp., 2004) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate P920034.
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 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/K040470 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040470: Tripter X-1 Compact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040470
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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