# K030346: Twinheads TH-101 Extracorporeal Shock Wave Lithotripter

- Pathway: 510(k) (Traditional)
- Applicant: Fmd, LLC
- Decided: May 2, 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 K003529 (2001). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003529: Sonolith Praktis, Endourology Table Praktis, Edap Technomed, Inc. (2001) Summary page 1.
- K011106: Stonelith, Model V5, Pck Electronic Industry and Trade Co, Ltd. (2002)

## Most influential descendants
- 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

## Indications for use
The TwinheadsO TH-10 1 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Source page: https://510kreport.com/device/K030346
Methodology: https://510kreport.com/methodology