510(k) · Cleared
ClearedDornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Aug 31, 2001 as substantially equivalent to P840008 (Dornier Medtech America, Inc., 1984) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1984. 14 later devices descend from it.
- Decided
- Aug 31, 2001
- Review
- 77 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P840008 (1984). 2 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 1 generation backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- This deviceK011873 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 · 3 generations on · 6 of its ownK053640 IntegraDirex Systems Corp. · 2006
- Descendant · 3 generations on · 3 of its ownK062147 Integra SLDirex Systems Corp. · 2006
- Descendant · 4 generations on · 2 of its ownK072538 Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K040470Tripter X-1 CompactDirex Systems Corp. · 2004 · cites it directly9descendants
- 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
- K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | Dornier Medtech America, Inc. | 1984 | — |
| 0 (this device) | 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 | — |
| +3 | K053640 | Integra | Direx Systems Corp. | 2006 | — |
| +3 | K062147 | Integra SL | Direx Systems Corp. | 2006 | — |
| +4 | K072538 | Piezolith 3000 Triple-Focus Lithotripter | United Medical Systems, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | P840008 | Dornier Lithotripter Compact Transportable (DLCT)Summary page 1…ased upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices, which includes the following: Dornier MFL5000 (P840008 / S24/S40/545), Dornier Lithotripter S (P840008 / S64) and Siemens Lithostar C (P870018 / S11). Submitter’s Name, Address, Telep… | 1984 |
| * | P870018 | LithostarSummary page 1…tiveness of its predicate devices, which includes the following: Dornier MFL5000 (P840008 / S24/S40/545), Dornier Lithotripter S (P840008 / S64) and Siemens Lithostar C (P870018 / S11). Submitter’s Name, Address, Telephone Number, Contact Person and Date Prepared Dornier Medical Systems, Inc. A Phone: 77… | 1988 |
What descends from it? (14)
See all 143 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?
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?
Indicated for the fragmentation of 5-25 mm kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle and lower ureteral stones > 4mm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011873: Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011873
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026