# K092033: Vibrolith and Vibrolith Plus  Intracorporeal Lithotriptor

- Pathway: 510(k) (Traditional)
- Applicant: Elmed USA
- Decided: Apr 30, 2010 after 298 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K863642 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012445: Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra), Electro Medical Systems SA (2001) Summary page 3.
- K963285: Ems Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1997) Summary page 3.

## Indications for use
This unit is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

Source page: https://510kreport.com/device/K092033
Methodology: https://510kreport.com/methodology