510(k) · Cleared
ClearedSwiss LithoClast Trilogy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.M.S Electro Medical Systems S.A · FFK Lithotriptor, Electro-Hydraulic
Cleared on May 29, 2019 as substantially equivalent to K182490 (E.M.S Electro Medical Systems S.A, 2018) after a 30-day review. Its family tree reaches back 7 generations to 1986. 1 later device descends from it.
- Decided
- May 29, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- FFK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K863642 (1986). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
- 6 generations backK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- 5 generations backK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · Recalled
- 4 generations backK173234 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- 3 generations backK181364 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- 2 generations backK181997 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- 1 generation backK182490 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- This deviceK191124 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2019
- Descendant · cites it directly · 0 of its ownK230893 Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.A · 2023
Most influential descendants
Showing 1 of 1 · See all- K230893Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.A · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K863642 | Candela Model MDL-1 Laser Lithotriptor | Candela Corp. | 1986 | — |
| −6 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| −5 | K012445 | Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) | Electro Medical Systems SA | 2001 | 3 |
| −4 | K173234 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| −3 | K181364 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| −2 | K181997 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| −1 | K182490 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| 0 (this device) | K191124 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2019 | — |
| +1 | K230893 | Swiss LthoClast Trilogy | E.M.S Electro Medical Systems S.A | 2023 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K182490 | Swiss LithoClast TrilogySummary page 4…Review Panel: 78 Gastroenterology / Urology Class: II E. Predicate Device(s): Swiss LithoClast® Trilogy: K182490 F. Summary Device Description: The Swiss LithoClast® Trilogy offers three modes of lithotripsy: 1) ultrasound alone; 2)… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230893 | Swiss LthoClast Trilogy | 2023 | 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?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K230893 (E.M.S Electro Medical Systems S.A, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FFK devicesFFK Lithotriptor, Electro-Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter
and bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191124 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191124: Swiss LithoClast Trilogy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191124
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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