510(k) · Cleared
ClearedSwiss Lithoclast Master Handpiece and 3.2 MM Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Consultants, Inc. · FFK Lithotriptor, Electro-Hydraulic
Cleared on Dec 18, 1997 as substantially equivalent to K951531 (Electro Medical Systems SA, 1995) and 1 other predicate after a 43-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it.
- Decided
- Dec 18, 1997
- Review
- 43 days
- Class
- Class II
- Product code
- FFK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K863642 (1986). 5 ancestors in all. 2 later devices descend from it, 1 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 deviceK974164 Swiss Lithoclast Master Handpiece and 3.2 MM ProbeMedical Device Consultants, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK062475 Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MMThe Laryngeal Mask Co., Ltd. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK123038 Swiss LithobreakerE.M.S Electro Medical Systems S.A · 2013
Most influential descendants
Showing 2 of 2 · See allView 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) | 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 |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K951531 | Swiss Lithoclast LithotripterSummary page 2…. Basis For Substantial Equivalence MASTER Handpiece The MASTER Handpiece is substantially equivalent to the EMS Standard Handpiece that was cleared for marketing under K951531 and K963285. The main difference between the two devices is that the MASTER Handpiece is sealed at both the distal and proximal e… | 1995 |
| * | K963285 | Ems Swiss Lithoclast LithotripterSummary page 2…Substantial Equivalence MASTER Handpiece The MASTER Handpiece is substantially equivalent to the EMS Standard Handpiece that was cleared for marketing under K951531 and K963285. The main difference between the two devices is that the MASTER Handpiece is sealed at both the distal and proximal ends, while t… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062475 | Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MM | 2007 | 1 |
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 11 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K062475 (The Laryngeal Mask Co., Ltd., 2007) has gone furthest, with 1 descendant 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 Swiss LITHOCLAST® MASTER HANDPIECE and the 3.2 MM PROBE are intended to be used as accessories to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or semirigid endoscopes. The 3.2 mm Probe is specifically indicated for use in fragmenting large stones in the bladder and kidney.
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/K974164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974164: Swiss Lithoclast Master Handpiece and 3.2 MM Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974164
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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