510(k) · Cleared
ClearedGemini XXP-HP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier Medtech America · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Jul 30, 2015 as substantially equivalent to K132672 (Dornier Medtech America, 2013) after a 76-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Jul 30, 2015
- Review
- 76 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to P840008 (1984). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- 3 generations backK011773 Dornier Lithotripter 140(Doli 140)Dornier · 2001
- 2 generations backK121656 Gemini LithotripterDornier Medtech America, Inc. · 2012
- 1 generation backK132672 Extra Corporeal Shockwave LithotripterDornier Medtech America · 2013
- This deviceK151298 Gemini XXP-HPDornier Medtech America · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | Dornier Medtech America, Inc. | 1984 | — |
| −3 | K011773 | Dornier Lithotripter 140(Doli 140) | Dornier | 2001 | — |
| −2 | K121656 | Gemini Lithotripter | Dornier Medtech America, Inc. | 2012 | — |
| −1 | K132672 | Extra Corporeal Shockwave Lithotripter | Dornier Medtech America | 2013 | — |
| 0 (this device) | K151298 | Gemini XXP-HP | Dornier Medtech America | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2001 | 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? (1)
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 |
|---|---|---|---|
| * | K132672 | Extra Corporeal Shockwave LithotripterSummary page 4…ock wave lithotripters as Class II devices with special controls. The Product Code for these lithotripters is LNS. Predicate Device Dornier Gemini 220 XP Lithotripter (K132672) Reference Devices Storz Modulith SLX-F2 180 (K072788) Siemens Lithoskop/Pulso (K070665) Purpose of the 510(k) Notice The Gem… | 2013 |
| † | K072788 | Storz Modulith Lithotripter SLX-F2-F180 | 2007 |
| † | K070665 | Lithoskop | 2008 |
| † | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 3 companies; a new generation was cleared every 11.3 years on median.
- None of the 7 ancestors has a recall.
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. 2015, 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 XXP-HP 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/K151298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151298: Gemini XXP-HP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151298
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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