510(k) · Cleared
ClearedGemini Lithotripter
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
Cleared on Sep 24, 2012 as substantially equivalent to P840008 (Dornier Medtech America, Inc., 1984) and 1 other predicate after a 111-day review. Its family tree reaches back 2 generations to 1984. 6 later devices descend from it.
- Decided
- Sep 24, 2012
- Review
- 111 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to P840008 (1984). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- 1 generation backK011773 Dornier Lithotripter 140(Doli 140)Dornier · 2001
- This deviceK121656 Gemini LithotripterDornier Medtech America, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK133434 Genesis IIDornier Medtech America, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK151485 GenesisDornier Medtech America, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK132672 Extra Corporeal Shockwave LithotripterDornier Medtech America · 2013
- Descendant · 3 generations on · 0 of its ownK220871 NautilusDornier Medtech America, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK151298 Gemini XXP-HPDornier Medtech America · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133434Genesis IIDornier Medtech America, Inc. · 2014 · cites it directly2descendants
- K151485GenesisDornier Medtech America, Inc. · 2015 · 2 generations on1descendant
- K132672Extra Corporeal Shockwave LithotripterDornier Medtech America · 2013 · cites it directly1descendant
- K220871NautilusDornier Medtech America, Inc. · 2022 · 3 generations on0descendants
- K151298Gemini XXP-HPDornier Medtech America · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | Dornier Medtech America, Inc. | 1984 | — |
| −1 | K011773 | Dornier Lithotripter 140(Doli 140) | Dornier | 2001 | — |
| 0 (this device) | K121656 | Gemini Lithotripter | Dornier Medtech America, Inc. | 2012 | — |
| +1 | K133434 | Genesis II | Dornier Medtech America, Inc. | 2014 | — |
| +2 | K151485 | Genesis | Dornier Medtech America, Inc. | 2015 | — |
| +1 | K132672 | Extra Corporeal Shockwave Lithotripter | Dornier Medtech America | 2013 | — |
| +3 | K220871 | Nautilus | Dornier Medtech America, Inc. | 2022 | — |
| +2 | K151298 | Gemini XXP-HP | Dornier Medtech America | 2015 | — |
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 |
|---|---|---|
| 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P840008 | Dornier Lithotripter Compact Transportable (DLCT)Summary page 1…Classification Name Extracorporeal Shock Wave Lithotripters (21 C.F.R. § 876.5990) Predicate Devices Dornier Lithotripter (Doll) (P840008, S062) Dornier Lithotripter 140 (Doli 140) (K01 1773) Intended Use / Indications for Use T… | 1984 |
| Kept off the family tree | K061 | Dornier Lithotripter (Doll) Number could not be read | |
| * | K011773 | Dornier Lithotripter 140(Doli 140)Summary page 1…tripters (21 C.F.R. § 876.5990) Predicate Devices Dornier Lithotripter (Doll) (P840008, S062) Dornier Lithotripter 140 (Doli 140) (K01 1773) Intended Use / Indications for Use The Gemini is indicated for the fragmentation of urinary tract ston… | 2001 |
| † | K002929 | Dornier Compact Alpha Lithotripter | 2001 |
What descends from it? (6)
3 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?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 16.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K133434 (Dornier Medtech America, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate P840008.
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. 2012, this device’s year, is highlighted.
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 Gemini is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121656: Gemini Lithotripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121656
Report an extraction error
Are you the manufacturer?
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