510(k) · Cleared
ClearedDornier Lithotripter 140(Doli 140)
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 Jun 22, 2001 as substantially equivalent to K002929 (Dornier Medtech America, Inc., 2001) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1984. 7 later devices descend from it.
- Decided
- Jun 22, 2001
- Review
- 15 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. 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- This deviceK011773 Dornier Lithotripter 140(Doli 140)Dornier · 2001
- Descendant · cites it directly · 6 of its ownK121656 Gemini LithotripterDornier Medtech America, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK133434 Genesis IIDornier Medtech America, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK151485 GenesisDornier Medtech America, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK132672 Extra Corporeal Shockwave LithotripterDornier Medtech America · 2013
- Descendant · 4 generations on · 0 of its ownK220871 NautilusDornier Medtech America, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121656Gemini LithotripterDornier Medtech America, Inc. · 2012 · cites it directly6descendants
- K133434Genesis IIDornier Medtech America, Inc. · 2014 · 2 generations on2descendants
- K151485GenesisDornier Medtech America, Inc. · 2015 · 3 generations on1descendant
- K132672Extra Corporeal Shockwave LithotripterDornier Medtech America · 2013 · 2 generations on1descendant
- K220871NautilusDornier Medtech America, Inc. · 2022 · 4 generations on0descendants
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) | K011773 | Dornier Lithotripter 140(Doli 140) | Dornier | 2001 | — |
| +1 | K121656 | Gemini Lithotripter | Dornier Medtech America, Inc. | 2012 | — |
| +2 | K133434 | Genesis II | Dornier Medtech America, Inc. | 2014 | — |
| +3 | K151485 | Genesis | Dornier Medtech America, Inc. | 2015 | — |
| +2 | K132672 | Extra Corporeal Shockwave Lithotripter | Dornier Medtech America | 2013 | — |
| +4 | K220871 | Nautilus | Dornier Medtech America, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K002929 | Dornier Compact Alpha LithotripterSummary page 1…ation of the substantial equivalence as well as the safety and effectiveness of its predicate devices, which includes the following:) Domnier Compact Alpha Lithotripter (K002929) and Dornier Compact Delta Lithotripter (P840008 / S65. Submiitter’s Name, Address, Telephone Number, Contact Person and Date Pr… | 2001 |
| * | P840008 | Dornier Lithotripter Compact Transportable (DLCT)Summary page 1…he safety and effectiveness of its predicate devices, which includes the following:) Domnier Compact Alpha Lithotripter (K002929) and Dornier Compact Delta Lithotripter (P840008 / S65. Submiitter’s Name, Address, Telephone Number, Contact Person and Date Prepared Dornier Medical Systems, Inc. Phone: 770-… | 1984 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121656 | Gemini Lithotripter | 2012 | 6 |
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?
The Dornier Lithotripter 140 (“Doli 140”) is indicated for fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.
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/K011773 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011773: Dornier Lithotripter 140(Doli 140).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011773
Report an extraction error
Are you the manufacturer?
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