# K072538: Piezolith 3000 Triple-Focus Lithotripter

- Pathway: 510(k) (Traditional)
- Applicant: United Medical Systems, Inc.
- Decided: Jan 30, 2008 after 145 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: 6 generations back to P840008 (1984). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032958: Piezolith 3000 Lithotripter, Model 3000, United Medical Systems, Inc. (2004) Summary page 1.
- K010340: Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral Calculi, Karl Storz Lithotripsy-America, Inc. (2001) Summary page 1.
- K012482: Storz Modulith SLK Lithotripter with Multiview Option, KARL STORZ Endoscopy-America, Inc. (2001) Summary page 1.
- K011700: Modulith SLK Lithotripter, Karl Storz Endoscopy (2002) Summary page 1.
- K053640: Integra, Direx Systems Corp. (2006) Summary page 1.
- K062147: Integra SL, Direx Systems Corp. (2006) Summary page 1.

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

## Indications for use
The Piezolith 3000 Triple-Focus 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/K072538
Methodology: https://510kreport.com/methodology