PMA · Approved
ApprovedDornier Lithotripter Compact Transportable (DLCT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier Medtech America, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Approved on Dec 19, 1984 through premarket approval, which rests on the device’s own clinical evidence after a 301-day review. 34 later devices descend from it.
- Decided
- Dec 19, 1984
- Review
- 301 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
34 later devices descend from it, 7 citing it directly.
- This deviceP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- Descendant · cites it directly · 14 of its ownK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
- Descendant · cites it directly · 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 · cites it directly · 7 of its ownK011773 Dornier Lithotripter 140(Doli 140)Dornier · 2001
- Descendant · cites it directly · 6 of its ownK121656 Gemini LithotripterDornier Medtech America, Inc. · 2012
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K011873Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP)Dornier · 2001 · cites it directly14descendants
- K040470Tripter X-1 CompactDirex Systems Corp. · 2004 · cites it directly9descendants
- K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004 · 2 generations on8descendants
- K011773Dornier Lithotripter 140(Doli 140)Dornier · 2001 · cites it directly7descendants
- K121656Gemini LithotripterDornier Medtech America, Inc. · 2012 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +1 | K040470 | Tripter X-1 Compact | Direx Systems Corp. | 2004 | — |
| +2 | K041582 | Modification to Tripter X-1 Compact Duet | Direx Systems Corp. | 2004 | — |
| +1 | K011773 | Dornier Lithotripter 140(Doli 140) | Dornier | 2001 | — |
| +1 | K121656 | Gemini Lithotripter | Dornier Medtech America, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (34)
See all 347 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011873 | Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) | 2001 | 14 |
| K040470 | Tripter X-1 Compact | 2004 | 9 |
| K011773 | Dornier Lithotripter 140(Doli 140) | 2001 | 7 |
| K121656 | Gemini Lithotripter | 2012 | 6 |
| K063504 | Econolith EM1000 | 2007 | 6 |
| K170122 | Delta III Lithotripter | 2017 | 3 |
| K101482 | EM-9000 | 2011 | 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?
- Of its descendants, K011873 (Dornier, 2001) has gone furthest, with 14 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/P840008 · printed Nov 6, 2026
Cite this page
510(k) Report. “P840008: Dornier Lithotripter Compact Transportable (DLCT).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P840008
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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