510(k) · Cleared
ClearedSwiss LthoClast 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 Oct 23, 2023 as substantially equivalent to K191124 (E.M.S Electro Medical Systems S.A, 2019) after a 206-day review. Its family tree reaches back 8 generations to 1986.
- Decided
- Oct 23, 2023
- Review
- 206 days
- Class
- Class II
- Product code
- FEO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K863642 (1986). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
- 7 generations backK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- 6 generations backK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · Recalled
- 5 generations backK173234 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- 4 generations backK181364 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- 3 generations backK181997 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- 2 generations backK182490 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- 1 generation backK191124 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2019
- This deviceK230893 Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.A · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K863642 | Candela Model MDL-1 Laser Lithotriptor | Candela Corp. | 1986 | — |
| −7 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| −6 | K012445 | Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) | Electro Medical Systems SA | 2001 | 3 |
| −5 | K173234 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| −4 | 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 | — |
| −2 | K182490 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| −1 | K191124 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2019 | — |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K191124 | Swiss LithoClast TrilogySummary page 4…eview Panel: 78 Gastroenterology / Urology Class: II E. Predicate Device(s): Swiss LithoClast ® Trilogy: K191124 F. Summary Device Description: The Swiss LithoClast® Trilogy offers three modes of lithotripsy: 1) ultrasound alone; 2)… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All FEO devicesFEO Lithotriptor, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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/K230893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230893: Swiss LthoClast Trilogy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230893
Report an extraction error
Are you the manufacturer?
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