# K123038: Swiss Lithobreaker

- Pathway: 510(k) (Traditional)
- Applicant: E.M.S Electro Medical Systems S.A
- Decided: Jan 16, 2013 after 110 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: 4 generations back to K863642 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 1.
- K062475: Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MM, The Laryngeal Mask Co., Ltd. (2007) Summary page 1.

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

Source page: https://510kreport.com/device/K123038
Methodology: https://510kreport.com/methodology