510(k) · Cleared
Recalled · 2009Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro Medical Systems SA · FFK Lithotriptor, Electro-Hydraulic
Cleared on Aug 24, 2001 as substantially equivalent to K951531 (Electro Medical Systems SA, 1995) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 1986. 15 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 24, 2001
- Review
- 23 days
- Class
- Class II
- Product code
- FFK
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K863642 (1986). 5 ancestors in all. 15 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
- 1 generation backK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- This deviceK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001
- Descendant · cites it directly · 6 of its ownK052135 Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · Recalled
- Descendant · cites it directly · 5 of its ownK173234 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- Descendant · 2 generations on · 5 of its ownK102169 Cyberwand LithotripterCybersonics, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK181364 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- Descendant · 3 generations on · 3 of its ownK181997 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K052135Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · cites it directly6descendants
- K173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018 · cites it directly5descendants
- K102169Cyberwand LithotripterCybersonics, Inc. · 2010 · 2 generations on5descendants
- K181364Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018 · 2 generations on4descendants
- K181997Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863642 | Candela Model MDL-1 Laser Lithotriptor | Candela Corp. | 1986 | — |
| −1 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| 0 (this device) | K012445 | Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) | Electro Medical Systems SA | 2001 | — |
| +1 | K052135 | Cybersonics Cyberwand Dual Probe Lithotripter | Cybersonics, Inc. | 2005 | 1 |
| +1 | K173234 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| +2 | K102169 | Cyberwand Lithotripter | Cybersonics, Inc. | 2010 | — |
| +2 | K181364 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| +3 | K181997 | 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 |
|---|---|---|
| 2005 | 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 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K951531 | Swiss Lithoclast LithotripterSummary page 1…calculi in the kidney, ureter, and bladder. 4. DEVICE DESCRIPTION The Swiss LithoClast® Master is a modified version of the Swiss LithoClast” previously cleared under K951531 and K963285. Three possible modes of operation are available using the Swiss LithoClast® Master: (1) pneumatic lithotripsy alone;… | 1995 |
| * | K963285 | Ems Swiss Lithoclast LithotripterSummary page 1…the kidney, ureter, and bladder. 4. DEVICE DESCRIPTION The Swiss LithoClast® Master is a modified version of the Swiss LithoClast” previously cleared under K951531 and K963285. Three possible modes of operation are available using the Swiss LithoClast® Master: (1) pneumatic lithotripsy alone; (2) ultraso… | 1997 |
| * | — | Storz Ultrasound Lithotripters Named without a submission number | |
| * | — | Richard Wolf Ultrasound Generator Named without a submission number |
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2009 | Not classified | Z-0175-2010 | Other | 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 840-7170." |
| Mar 16, 2005 | Not classified | Z-0684-2007 | Other | Handpiece may become dislodged causing cable damage and possible electric shock. |
| Oct 3, 2003 | Not classified | Z-0078-04 | Other | Failure of foot pedal to activate device |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K052135 (Cybersonics, Inc., 2005) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K951531.
How does its category compare?
All FFK devicesFFK Lithotriptor, Electro-Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FFK
110in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFK
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFK
6in 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® Master is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.
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/K012445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012445: Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012445
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026