510(k) · Cleared
ClearedStonelith, Model V5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pck Electronic Industry and Trade Co, Ltd. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Feb 11, 2002 after a 306-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Feb 11, 2002
- Review
- 306 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK011106 Stonelith, Model V5Pck Electronic Industry and Trade Co, Ltd. · 2002
- Descendant · cites it directly · 10 of its ownK023535 Tripter X-1 Compact DuetDirex Systems Corp. · 2003
- Descendant · 2 generations on · 9 of its ownK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
- Descendant · 2 generations on · 8 of its ownK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
- Descendant · 3 generations on · 6 of its ownK053640 IntegraDirex Systems Corp. · 2006
- Descendant · 3 generations on · 3 of its ownK062147 Integra SLDirex Systems Corp. · 2006
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K023535Tripter X-1 Compact DuetDirex Systems Corp. · 2003 · cites it directly10descendants
- K040470Tripter X-1 CompactDirex Systems Corp. · 2004 · 2 generations on9descendants
- K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004 · 2 generations on8descendants
- K053640IntegraDirex Systems Corp. · 2006 · 3 generations on6descendants
- K062147Integra SLDirex Systems Corp. · 2006 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011106 | Stonelith, Model V5 | Pck Electronic Industry and Trade Co, Ltd. | 2002 | — |
| +1 | K023535 | Tripter X-1 Compact Duet | Direx Systems Corp. | 2003 | — |
| +2 | K040470 | Tripter X-1 Compact | Direx Systems Corp. | 2004 | — |
| +2 | K041582 | Modification to Tripter X-1 Compact Duet | Direx Systems Corp. | 2004 | — |
| +3 | K053640 | Integra | Direx Systems Corp. | 2006 | — |
| +3 | K062147 | Integra SL | Direx Systems Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 153 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?
- Of its descendants, K023535 (Direx Systems Corp., 2003) has gone furthest, with 10 descendants of its own.
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 | — |
https://510kreport.com/device/K011106 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011106: Stonelith, Model V5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011106
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026