# K200419: Kalera Vacuum Aspiration Catheter (K-VAC)

- Pathway: 510(k) (Traditional)
- Applicant: Kalera Medical, Inc.
- Decided: May 22, 2020 after 92 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K770378 (1977). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161110: ClearPetra Suction-Evacuation Sheath, Well Lead Medical Co., Ltd. (2016) Summary page 4.

## Indications for use
The Kalera Vacuum Aspiration Catheter (K-VAC™) is used to establish a conduit during endoscopic urological procedures for the treatment of urinary stones.

Source page: https://510kreport.com/device/K200419
Methodology: https://510kreport.com/methodology