# K032958: Piezolith 3000 Lithotripter, Model 3000

- Pathway: 510(k) (Traditional)
- Applicant: United Medical Systems, Inc.
- Decided: Feb 17, 2004 after 148 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Richard Wolf Piezolith E.P.L. Lithotripter, Model 2300: named in the summary without a submission number
- (no number) Dornier Compact S: named in the summary without a submission number
- (no number) Dornier Compact Delta: named in the summary without a submission number
- (no number) Siemens Modularis Litho: named in the summary without a submission number
- (no number) Storz Modulith SLX: named in the summary without a submission number
- (no number) Storz Modulith SLK: named in the summary without a submission number

## Most influential descendants
- K072538: Piezolith 3000 Triple-Focus Lithotripter (2008), 2 descendants of its own
- K252913: Break Wave (2026), 1 descendant of its own
- K261086: Break Wave (2026), 0 descendants of its own

## Indications for use
The Piezolith 3000 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/K032958
Methodology: https://510kreport.com/methodology