510(k) · Cleared

Cleared

Ems Swiss Lithoclast Lithotripter

K963285510(k) TraditionalCleared Feb 13, 1997176-day reviewClass II21 CFR 876.4480

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Electro Medical Systems SA · FFK Lithotriptor, Electro-Hydraulic

Cleared on Feb 13, 1997 as substantially equivalent to K951531 (Electro Medical Systems SA, 1995) and 3 other predicates after a 176-day review. Its family tree reaches back 1 generation to 1986. 22 later devices descend from it.

Decided: Feb 13, 1997
Review: 176 days
Class: Class II
Product code: FFK
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K863642 (1986). 4 ancestors in all. 22 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
This deviceK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
Descendant · cites it directly · 15 of its ownK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · Recalled
Descendant · 2 generations on · 6 of its ownK052135 Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · Recalled
Descendant · 2 generations on · 5 of its ownK173234 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
Descendant · 3 generations on · 5 of its ownK102169 Cyberwand LithotripterCybersonics, Inc. · 2010
Descendant · 3 generations on · 4 of its ownK181364 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

1997high 4 (2018) · low 0 (2000)2026

Most influential descendants

Showing 5 of 22 · See all

K012445Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · cites it directly15descendants
K052135Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · 2 generations on6descendants
K173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018 · 2 generations on5descendants
K102169Cyberwand LithotripterCybersonics, Inc. · 2010 · 3 generations on5descendants
K181364Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863642	Candela Model MDL-1 Laser Lithotriptor	Candela Corp.	1986	—
0 (this device)	K963285	Ems Swiss Lithoclast Lithotripter	Electro Medical Systems SA	1997	—
+1	K012445	Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)	Electro Medical Systems SA	2001	3
+2	K052135	Cybersonics Cyberwand Dual Probe Lithotripter	Cybersonics, Inc.	2005	1
+2	K173234	Swiss LithoClast Trilogy	E.M.S Electro Medical Systems S.A	2018	—
+3	K102169	Cyberwand Lithotripter	Cybersonics, Inc.	2010	—
+3	K181364	Swiss LithoClast Trilogy	E.M.S Electro Medical Systems S.A	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1992	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	2	0
1999	2	0
2001	1	0
2005	1	0
2007	1	0
2010	2	0
2012	2	0
2013	2	0
2014	1	0
2017	1	0
2018	4	0
2019	1	0
2023	1	0

FIG. 1 — Lineage of K963285, 1986–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FFK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FFK device

#1 K230488 EL27-Compact; Sterile EHL-Probesscore 12.2 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K951531	Swiss Lithoclast Lithotripter Summary page 1 …n Name: Electrohydraulic Lithotripter 5. Device Classification: Class III 6. Predicate Devices: . EMS SWISS LITHOCLAST LITHOTRIPTER (for ureteral and bladder stones) K951531 . Wolf 2270 Ultrasound Generator and Sonatrodes . Wolf 2280 Electrohydraulic Lithotripter (K923487) . Candela LaserTripter (K8636…	Electro Medical Systems SA	1995	—
*	K913487	Riwolith 2280 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”.	Richard Wolf Medical Instruments Corp.	1992	—
*	K863642	Candela Model MDL-1 Laser Lithotriptor Summary page 1 …ER (for ureteral and bladder stones) K951531 . Wolf 2270 Ultrasound Generator and Sonatrodes . Wolf 2280 Electrohydraulic Lithotripter (K923487) . Candela LaserTripter (K863642/K885255) 7. Intended Use: The EMS SWIss LITHOCLAST LITHOTRIPTER is intended for use in fragmenting urinary tract calculi (renal…	Candela Corp.	1986	—
*	K885255	MDL-1 Lasertripter (TM) Summary page 1 …ureteral and bladder stones) K951531 . Wolf 2270 Ultrasound Generator and Sonatrodes . Wolf 2280 Electrohydraulic Lithotripter (K923487) . Candela LaserTripter (K863642/K885255) 7. Intended Use: The EMS SWIss LITHOCLAST LITHOTRIPTER is intended for use in fragmenting urinary tract calculi (renal, ureter…	Candela Laser Corp.	1989	—
*	—	Wolf 2270 Ultrasound Generator and Sonatrodes Named without a submission number			—

Also cleared against K951531: 7 other devices →

What descends from it? (22)

See all 22

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012445	Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)	Electro Medical Systems SA	2001	15
K974164	Swiss Lithoclast Master Handpiece and 3.2 MM Probe	Medical Device Consultants, Inc.	1997	2
K062475	Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MM	The Laryngeal Mask Co., Ltd.	2007	1
K092033	Vibrolith and Vibrolith Plus Intracorporeal Lithotriptor	Elmed USA	2010	0
K992114	Ksea Calcusplit	Karl Storz Endoscopy	1999	0
K992251	Swiss Lithoclast Multipurpose Probe	Electro Medical Systems SA	1999	0
K981233	Ksea Calcusplit	KARL STORZ Endoscopy-America, Inc.	1998	0
K974796	Lithospec (TM) Intracorporeal Lithotripter	Medispec, Ltd.	1998	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 4 ancestors has a recall.
Of its descendants, K012445 (Electro Medical Systems SA, 2001) has gone furthest, with 15 descendants of its own.
7 other devices also cite its predicate K951531.

How does its category compare?

All FFK devices

FFK Lithotriptor, Electro-Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FFK

2in 2025

2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FFK

110in 2013

2007high 110 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FFK

1in 2021

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FFK

6in 2025

2007high 39 (2020) · low 2 (2012)2025

MAUDE reports naming product code FFK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	1	6
2008	0	—	0	12
2009	0	—	1	35
2010	2	—	0	16
2011	0	—	0	6
2012	2	—	0	2
2013	3	110	0	10
2014	0	—	0	9
2015	0	—	0	7
2016	2	—	0	7
2017	0	—	1	9
2018	0	—	0	18
2019	1	—	0	10
2020	0	—	0	39
2021	1	—	1	22
2022	0	—	0	13
2023	1	—	0	10
2024	0	—	0	8
2025	2	—	0	6
2026	0	—	0	—

What is it indicated for?

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K963285 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963285: Ems Swiss Lithoclast Lithotripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963285

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026