510(k) · Cleared
ClearedIntegra SL
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 Oct 20, 2006 as substantially equivalent to K053640 (Direx Systems Corp., 2006) and 1 other predicate after an 85-day review. Its family tree reaches back 5 generations to 1984. 3 later devices descend from it.
- Decided
- Oct 20, 2006
- Review
- 85 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to P840008 (1984). 16 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- 4 generations backK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
- 3 generations backK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
- 2 generations backK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
- 1 generation backK053640 IntegraDirex Systems Corp. · 2006
- This deviceK062147 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
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | Dornier Medtech America, Inc. | 1984 | — |
| −4 | K011873 | Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) | Dornier | 2001 | — |
| −3 | K040470 | Tripter X-1 Compact | Direx Systems Corp. | 2004 | — |
| −2 | K041582 | Modification to Tripter X-1 Compact Duet | Direx Systems Corp. | 2004 | — |
| −1 | K053640 | Integra | Direx Systems Corp. | 2006 | — |
| 0 (this device) | 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 | — |
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 |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K053640 | IntegraSummary page 1…ass 1I(special controls) Product code: 78 LNS Panel: Gastroenterology and Urology 3. Predicate Devices Direx Integra (K053640) Direx Tripter X - 1 Compact Duet (K041 582) 5-1 4. Intended Use:… | 2006 |
| * | K041582 | Modification to Tripter X-1 Compact DuetSummary page 1…78 LNS Panel: Gastroenterology and Urology 3. Predicate Devices Direx Integra (K053640) Direx Tripter X - 1 Compact Duet (K041 582) 5-1 4. Intended Use: Integra SL is intended to fragment urinary ston… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072538 | Piezolith 3000 Triple-Focus Lithotripter | 2008 | 2 |
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 1.6 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K072538 (United Medical Systems, Inc., 2008) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K053640.
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?
Integra SL 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/K062147 · printed Nov 3, 2026
Cite this page
510(k) Report. “K062147: Integra SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K062147
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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