# K151298: Gemini XXP-HP

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America
- Decided: Jul 30, 2015 after 76 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: 4 generations back to P840008 (1984). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132672: Extra Corporeal Shockwave Lithotripter, Dornier Medtech America (2013) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K151298
Methodology: https://510kreport.com/methodology