510(k) Report

510(k) · Cleared

Cleared

Swiss Lithoclast Lithotripter

K951531510(k) TraditionalCleared Aug 24, 1995143-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 Aug 24, 1995 after a 143-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.

Decided
Aug 24, 1995
Review
143 days
Class
Class II
Product code
FFK
Recalls
None
Predicates
0

23 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2007: 1 descendant cleared1997: 2 descendants cleared1998: 2 descendants cleared1999: 2 descendants cleared2010: 2 descendants cleared2005: 1 descendant cleared2018: 4 descendants cleared2012: 2 descendants cleared2013: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951531 Swiss Lithoclast LithotripterElectro Medical Systems SA · 1995
  2. Descendant · cites it directly · 22 of its ownK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
  3. Descendant · cites it directly · 15 of its ownK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · Recalled
  4. Descendant · 2 generations on · 6 of its ownK052135 Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · Recalled
  5. Descendant · 2 generations on · 5 of its ownK173234 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
  6. Descendant · 3 generations on · 5 of its ownK102169 Cyberwand LithotripterCybersonics, Inc. · 2010

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

1997: 21998: 21999: 22001: 12005: 12007: 12010: 22012: 22013: 22014: 12017: 12018: 42019: 12023: 1
1997high 4 (2018) · low 0 (2000)2026

Most influential descendants

Showing 5 of 23 · See all
  • K963285Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997 · cites it directly22descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951531Swiss Lithoclast LithotripterElectro Medical Systems SA1995—
+1K963285Ems Swiss Lithoclast LithotripterElectro Medical Systems SA1997—
+1K012445Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA20013
+2K052135Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc.20051
+2K173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018—
+3K102169Cyberwand LithotripterCybersonics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199820
199920
200110
200510
200710
201020
201220
201320
201410
201710
201840
201910
202310
FIG. 1 — Lineage of K951531, 1995–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K230488 EL27-Compact; Sterile EHL-Probesscore 12.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K963285Ems Swiss Lithoclast LithotripterElectro Medical Systems SA199722
K012445Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA200115
K974164Swiss Lithoclast Master Handpiece and 3.2 MM ProbeMedical Device Consultants, Inc.19972
K062475Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MMThe Laryngeal Mask Co., Ltd.20071
K992114Ksea CalcusplitKarl Storz Endoscopy19990
K992251Swiss Lithoclast Multipurpose ProbeElectro Medical Systems SA19990
K981233Ksea CalcusplitKARL STORZ Endoscopy-America, Inc.19980
K974796Lithospec (TM) Intracorporeal LithotripterMedispec, Ltd.19980

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?

  • Of its descendants, K963285 (Electro Medical Systems SA, 1997) has gone furthest, with 22 descendants of its own.

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

2007: 22010: 22012: 22013: 32016: 22019: 12021: 12023: 12025: 2
2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FFK

110in 2013

2013: 110 days median
2007high 110 (2013)2026

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

Recalls per year · FFK

1in 2021

2007: 12009: 12017: 12021: 1
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

2007: 62008: 122009: 352010: 162011: 62012: 22013: 102014: 92015: 72016: 72017: 92018: 182019: 102020: 392021: 222022: 132023: 102024: 82025: 6
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—16
20080—012
20090—135
20102—016
20110—06
20122—02
20133110010
20140—09
20150—07
20162—07
20170—19
20180—018
20191—010
20200—039
20211—122
20220—013
20231—010
20240—08
20252—06
20260—0—

More from Electro Medical Systems SA

9 FDA decisions under this applicant name. See the company

  • K022328Ems Piezon Master 600Electro Medical Systems SA · 2002
  • K022119Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
  • K012445Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 20013 recalls
  • K002484Ems Swiss Orthoclast Chisels for Non-Cemented Prosthesis RemovalElectro Medical Systems SA · 2000
  • K992251Swiss Lithoclast Multipurpose ProbeElectro Medical Systems SA · 1999

Recent decisions in FFK

The FFK category page

  • K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
  • K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
  • K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH · 2023
  • K202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc. · 2021
  • K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2019

https://510kreport.com/device/K951531 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951531: Swiss Lithoclast Lithotripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951531

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026