# K041582: Modification to Tripter X-1 Compact Duet

- Pathway: 510(k) (Special)
- Applicant: Direx Systems Corp.
- Decided: Jul 7, 2004 after 23 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: 3 generations back to P840008 (1984). 12 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023535: Tripter X-1 Compact Duet, Direx Systems Corp. (2003) Summary page 1.
- K040470: Tripter X-1 Compact, Direx Systems Corp. (2004) Summary page 1.

## Most influential descendants
- 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
- K252913: Break Wave (2026), 1 descendant of its own
- K261086: Break Wave (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K041582
Methodology: https://510kreport.com/methodology