# K190492: Peralta Stone Removal Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Calcula Technologies, Inc.
- Decided: Jul 18, 2019 after 140 days
- Product code: FFL (Dislodger, Stone, Basket, Ureteral, Metal)
- Device class: 2
- Regulation: 21 CFR 876.4680
- 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 K831875 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831875: Balloon Dilation Helical Stone Extract, Vpi (1983) Summary page 4.
- K941853: Passport, Boston Scientific Corp (1994) Summary page 4.

## Indications for use
The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.

Source page: https://510kreport.com/device/K190492
Methodology: https://510kreport.com/methodology