510(k) · Cleared
ClearedSwiss Lithobreaker
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 Jan 16, 2013 as substantially equivalent to K012445 (Electro Medical Systems SA, 2001) and 1 other predicate after a 110-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Jan 16, 2013
- Review
- 110 days
- Class
- Class II
- Product code
- FFK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K863642 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
- 3 generations backK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- 2 generations backK974164 Swiss Lithoclast Master Handpiece and 3.2 MM ProbeMedical Device Consultants, Inc. · 1997
- 1 generation backK062475 Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MMThe Laryngeal Mask Co., Ltd. · 2007 · Recalled
- This deviceK123038 Swiss LithobreakerE.M.S Electro Medical Systems S.A · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K863642 | Candela Model MDL-1 Laser Lithotriptor | Candela Corp. | 1986 | — |
| −3 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| −2 | K974164 | Swiss Lithoclast Master Handpiece and 3.2 MM Probe | Medical Device Consultants, Inc. | 1997 | — |
| −1 | K062475 | Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MM | The Laryngeal Mask Co., Ltd. | 2007 | 7 |
| 0 (this device) | K123038 | Swiss Lithobreaker | E.M.S Electro Medical Systems S.A | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K012445 | Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Summary page 1…) (KO 12445) * The Laryngial Mask Company Limited, LMA StoneBreaker (K062475) The probes used by the SWISS LITHOBREAKER were previously cleared by FDA in K012445, and K973788. The LithoVac 1v3 suction system was previously cleared in K012445. The sterile drape was previously cleared in… | 2001 |
| * | K062475 | Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MMSummary page 1…* E.M.S. Electro Medical Systems S.A., Swiss Litholast Master (aka Swiss Litholast Ultra) (KO 12445) * The Laryngial Mask Company Limited, LMA StoneBreaker (K062475) The probes used by the SWISS LITHOBREAKER were previously cleared by FDA in K012445, and K973788. The LithoVac 1v3 su… | 2007 |
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 27 years and passes through 5 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 4 other devices also cite its predicate K012445.
How does its category compare?
All FFK devicesFFK Lithotriptor, Electro-Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 LITHOBREAKER is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123038: Swiss Lithobreaker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123038
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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