# K221903: Delta III Pro

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America, Inc.
- Decided: Feb 22, 2023 after 237 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: 4 generations back to P840008 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201074: Delta III Lithotripter, Dornier Medtech America, Inc. (2020) Summary page 4.

## Indications for use
The Delta Ill Pro Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

Source page: https://510kreport.com/device/K221903
Methodology: https://510kreport.com/methodology