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 · FEO Lithotriptor, Ultrasonic
Cleared on Aug 30, 2018 as substantially equivalent to K181364 (E.M.S Electro Medical Systems S.A, 2018) after a 35-day review. Its family tree reaches back 5 generations to 1986. 3 later devices descend from it.
- Decided
- Aug 30, 2018
- Review
- 35 days
- Class
- Class II
- Product code
- FEO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K863642 (1986). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
- 4 generations backK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- 3 generations backK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · Recalled
- 2 generations backK173234 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- 1 generation backK181364 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- This deviceK181997 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- Descendant · cites it directly · 2 of its ownK182490 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- Descendant · 2 generations on · 1 of its ownK191124 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2019
- Descendant · 3 generations on · 0 of its ownK230893 Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.A · 2023
Most influential descendants
Showing 3 of 3 · See all- K182490Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018 · cites it directly2descendants
- K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2019 · 2 generations on1descendant
- K230893Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.A · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K863642 | Candela Model MDL-1 Laser Lithotriptor | Candela Corp. | 1986 | — |
| −4 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| −3 | K012445 | Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) | Electro Medical Systems SA | 2001 | 3 |
| −2 | K173234 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| −1 | K181364 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| 0 (this device) | 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 | — |
| +2 | K191124 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2019 | — |
| +3 | 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 |
|---|---|---|
| 2018 | 1 | 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 FEO? 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 FEO device
- #1 K230893 Swiss LthoClast Trilogyscore 8.3 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K181364 | Swiss LithoClast TrilogySummary page 4…Review Panel: 78 Gastroenterology / Urology Class: II E. Predicate Device(s): Swiss LithoClast® Trilogy, K181364 F. Summary Device Description: The Swiss LithoClast® Trilogy is an intracorporal lithotripter with three possible m… | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182490 | Swiss LithoClast Trilogy | 2018 | 2 |
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 32 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K182490 (E.M.S Electro Medical Systems S.A, 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FEO devicesFEO Lithotriptor, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FEO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FEO
32in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FEO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEO
354in 2025
MAUDE reports naming product code FEO, 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 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 1 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 8 |
| 2018 | 4 | 32 | 0 | 9 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 128 |
| 2021 | 0 | — | 0 | 66 |
| 2022 | 0 | — | 0 | 30 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 221 |
| 2025 | 0 | — | 1 | 354 |
| 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/K181997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181997: Swiss LithoClast Trilogy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181997
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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