# K010340: Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral Calculi

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Lithotripsy-America, Inc.
- Decided: Feb 13, 2001 after 8 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
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023535: Tripter X-1 Compact Duet (2003), 10 descendants of its own
- 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

Source page: https://510kreport.com/device/K010340
Methodology: https://510kreport.com/methodology