# K121656: Gemini Lithotripter

- Pathway: 510(k) (Special)
- Applicant: Dornier Medtech America, Inc.
- Decided: Sep 24, 2012 after 111 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P840008 (1984). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P840008: Dornier Lithotripter Compact Transportable (DLCT), Dornier Medtech America, Inc. (1984) Summary page 1.
- K011773: Dornier Lithotripter 140(Doli 140), Dornier (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K061: Dornier Lithotripter (Doll). Number could not be read

## Most influential descendants
- K133434: Genesis II (2014), 2 descendants of its own
- K151485: Genesis (2015), 1 descendant of its own
- K132672: Extra Corporeal Shockwave Lithotripter (2013), 1 descendant of its own
- K220871: Nautilus (2022), 0 descendants of its own
- K151298: Gemini XXP-HP (2015), 0 descendants of its own

## Indications for use
The Gemini is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.

Source page: https://510kreport.com/device/K121656
Methodology: https://510kreport.com/methodology