# K963285: Ems Swiss Lithoclast Lithotripter

- Pathway: 510(k) (Traditional)
- Applicant: Electro Medical Systems SA
- Decided: Feb 13, 1997 after 176 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: 1 generation back to K863642 (1986). 4 ancestors in all.
22 later devices descend from it; 8 cite it directly.
0 of 27 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.
- K913487: Riwolith 2280, Richard Wolf Medical Instruments Corp. (1992). Our OCR of the scanned summary read K923487, FDA’s number for Bal Cath (Ballard Medical Products). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Wolf 2280 Electrohydraulic Lithotripter”.
- K863642: Candela Model MDL-1 Laser Lithotriptor, Candela Corp. (1986) Summary page 1.
- K885255: MDL-1 Lasertripter (TM), Candela Laser Corp. (1989) Summary page 1.
- (no number) Wolf 2270 Ultrasound Generator and Sonatrodes: named in the summary without a submission number

## Most influential descendants
- K012445: Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) (2001), 15 descendants of its own
- 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

## Indications for use
The EMS SWIss LITHOCLAST LITHOTRIPTER is intended for use in fragmenting urinary tract calculi (renal, ureteral, and bladder) through rigid or semirigid endoscopes.

Source page: https://510kreport.com/device/K963285
Methodology: https://510kreport.com/methodology