# K012445: Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)

- Pathway: 510(k) (Special)
- Applicant: Electro Medical Systems SA
- Decided: Aug 24, 2001 after 23 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K863642 (1986). 5 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951531: Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1995) Summary page 1.
- K963285: Ems Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1997) Summary page 1.
- (no number) Storz Ultrasound Lithotripters: named in the summary without a submission number
- (no number) Richard Wolf Ultrasound Generator: named in the summary without a submission number

## Most influential descendants
- K052135: Cybersonics Cyberwand Dual Probe Lithotripter (2005), 6 descendants of its own
- K173234: Swiss LithoClast Trilogy (2018), 5 descendants of its own
- K102169: Cyberwand Lithotripter (2010), 5 descendants of its own
- K181364: Swiss LithoClast Trilogy (2018), 4 descendants of its own
- K181997: Swiss LithoClast Trilogy (2018), 3 descendants of its own

## Recalls of this device
- Sep 17, 2009 · Not classified · Z-0175-2010: The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7
- Mar 16, 2005 · Not classified · Z-0684-2007: Handpiece may become dislodged causing cable damage and possible electric shock.
- Oct 3, 2003 · Not classified · Z-0078-04: Failure of foot pedal to activate device

## Indications for use
The EMS Swiss LithoClast® Master is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.

Source page: https://510kreport.com/device/K012445
Methodology: https://510kreport.com/methodology