# K023535: Tripter X-1 Compact Duet

- Pathway: 510(k) (Special)
- Applicant: Direx Systems Corp.
- Decided: Jan 17, 2003 after 88 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: 1 generation back to P920051 (1995). 4 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P920034: Tripter-X1 Nova, Medirex, Inc. (1996) Summary page 1.
- P920051: Storz Modulith (TM) Lithotripter, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 1.
- K010340: Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral Calculi, Karl Storz Lithotripsy-America, Inc. (2001)
- K011106: Stonelith, Model V5, Pck Electronic Industry and Trade Co, Ltd. (2002)

## Most influential descendants
- K040470: Tripter X-1 Compact (2004), 9 descendants of its own
- K041582: Modification to Tripter X-1 Compact Duet (2004), 8 descendants of its own
- K053640: Integra (2006), 6 descendants of its own
- K062147: Integra SL (2006), 3 descendants of its own
- K072538: Piezolith 3000 Triple-Focus Lithotripter (2008), 2 descendants of its own

## Indications for use
The Tripter-X1 Compact Duet Extracorporeal Shock Wave Lithotripter is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

Source page: https://510kreport.com/device/K023535
Methodology: https://510kreport.com/methodology