# K050091: Tripter-X1 Compact Duet SP (Separated Pulse)

- Pathway: 510(k) (Special)
- Applicant: Direx Systems Corp.
- Decided: Mar 16, 2005 after 61 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 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.
- K041582: Modification to Tripter X-1 Compact Duet, Direx Systems Corp. (2004) Summary page 1.
- K030346: Twinheads TH-101 Extracorporeal Shock Wave Lithotripter, Fmd, LLC (2003) Summary page 1.

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

Source page: https://510kreport.com/device/K050091
Methodology: https://510kreport.com/methodology