# K013471: Delta 2000 Series Extracorporeal Lithotripter

- Pathway: 510(k) (Traditional)
- Applicant: E.S.W.L. Products, Inc.
- Decided: Apr 29, 2002 after 193 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002929: Dornier Compact Alpha Lithotripter, Dornier Medtech America, Inc. (2001) Summary page 1.
- K003529: Sonolith Praktis, Endourology Table Praktis, Edap Technomed, Inc. (2001) 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.

## Indications for use
The Delta™ 2000 Series of Extracorporeal 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/K013471
Methodology: https://510kreport.com/methodology