# K003529: Sonolith Praktis, Endourology Table Praktis

- Pathway: 510(k) (Abbreviated)
- Applicant: Edap Technomed, Inc.
- Decided: Feb 12, 2001 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
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 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
- K030346: Twinheads TH-101 Extracorporeal Shock Wave Lithotripter (2003), 3 descendants of its own
- K083614: Sonolith I-Sys Lithotriper (2009), 1 descendant of its own
- K111808: Sonolith I-Move (2011), 0 descendants of its own
- K050091: Tripter-X1 Compact Duet SP (Separated Pulse) (2005), 0 descendants of its own
- K042561: Twinheads TH-103 Extracorporeal Shock Wave Lithotripter (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K003529
Methodology: https://510kreport.com/methodology