510(k) · Cleared
ClearedIntegra
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 Mar 1, 2006 as substantially equivalent to P920051 (KARL STORZ Endoscopy-America, Inc., 1995) and 3 other predicates after a 61-day review. Its family tree reaches back 4 generations to 1984. 6 later devices descend from it.
- Decided
- Mar 1, 2006
- Review
- 61 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to P840008 (1984). 15 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 4 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- 3 generations backK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
- 2 generations backK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
- 1 generation backK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
- This deviceK053640 IntegraDirex Systems Corp. · 2006
- Descendant · cites it directly · 3 of its ownK062147 Integra SLDirex Systems Corp. · 2006
- Descendant · cites it directly · 2 of its ownK072538 Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK252913 Break WaveSonomotion, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK261086 Break WaveSonomotion, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK111947 Duet MagnaDirex Systems Corp. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K062147Integra SLDirex Systems Corp. · 2006 · cites it directly3descendants
- K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008 · cites it directly2descendants
- K252913Break WaveSonomotion, Inc. · 2026 · 2 generations on1descendant
- K261086Break WaveSonomotion, Inc. · 2026 · 3 generations on0descendants
- K111947Duet MagnaDirex Systems Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | Dornier Medtech America, Inc. | 1984 | — |
| −3 | K011873 | Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) | Dornier | 2001 | — |
| −2 | K040470 | Tripter X-1 Compact | Direx Systems Corp. | 2004 | — |
| −1 | K041582 | Modification to Tripter X-1 Compact Duet | Direx Systems Corp. | 2004 | — |
| 0 (this device) | K053640 | Integra | Direx Systems Corp. | 2006 | — |
| +1 | K062147 | Integra SL | Direx Systems Corp. | 2006 | — |
| +1 | K072538 | Piezolith 3000 Triple-Focus Lithotripter | United Medical Systems, Inc. | 2008 | — |
| +2 | K252913 | Break Wave | Sonomotion, Inc. | 2026 | — |
| +3 | K261086 | Break Wave | Sonomotion, Inc. | 2026 | — |
| +1 | K111947 | Duet Magna | Direx Systems Corp. | 2012 | — |
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 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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 |
|---|---|---|---|
| * | P920051 | Storz Modulith (TM) LithotripterSummary page 1…controls) Product code: 78 LNS Panel: Gastroenterology and Urology 3. Predicate Devices Storz Modulith® SL-20/ (SLX) (P920051) Storz Modulith® Lithotripter Model SLK (K010340) Direx Tripter X - 1 Compact Duet (K041582) Direx 3Dscope (K041213)… | 1995 |
| * | K010340 | Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral…Summary page 1…Panel: Gastroenterology and Urology 3. Predicate Devices Storz Modulith® SL-20/ (SLX) (P920051) Storz Modulith® Lithotripter Model SLK (K010340) Direx Tripter X - 1 Compact Duet (K041582) Direx 3Dscope (K041213) 5-1 === Page… | 2001 |
| * | K041582 | Modification to Tripter X-1 Compact DuetSummary page 1…y and Urology 3. Predicate Devices Storz Modulith® SL-20/ (SLX) (P920051) Storz Modulith® Lithotripter Model SLK (K010340) Direx Tripter X - 1 Compact Duet (K041582) Direx 3Dscope (K041213) 5-1 4. Intended Use: The INTEGRA is intende… | 2004 |
| * | K041213 | 3DSCOPESummary page 1…ate Devices Storz Modulith® SL-20/ (SLX) (P920051) Storz Modulith® Lithotripter Model SLK (K010340) Direx Tripter X - 1 Compact Duet (K041582) Direx 3Dscope (K041213) 5-1 4. Intended Use: The INTEGRA is intended to fragment urinary stone… | 2004 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K062147 (Direx Systems Corp., 2006) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate P920051.
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 INTEGRA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053640: Integra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053640
Report an extraction error
Are you the manufacturer?
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