510(k) · Cleared
ClearedRiwolith 2280
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FFK Lithotriptor, Electro-Hydraulic
Cleared on Feb 5, 1992 after a 183-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 23 later devices descend from it.
- Decided
- Feb 5, 1992
- Review
- 183 days
- Class
- Class II
- Product code
- FFK
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 1 citing it directly.
- This deviceK913487 Riwolith 2280Richard Wolf Medical Instruments Corp. · 1992
- Descendant · cites it directly · 22 of its ownK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- Descendant · 2 generations on · 15 of its ownK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · Recalled
- Descendant · 3 generations on · 6 of its ownK052135 Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 5 of its ownK173234 Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018
- Descendant · 4 generations on · 5 of its ownK102169 Cyberwand LithotripterCybersonics, Inc. · 2010
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K963285Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997 · cites it directly22descendants
- K012445Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · 2 generations on15descendants
- K052135Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · 3 generations on6descendants
- K173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A · 2018 · 3 generations on5descendants
- K102169Cyberwand LithotripterCybersonics, Inc. · 2010 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913487 | Riwolith 2280 | Richard Wolf Medical Instruments Corp. | 1992 | — |
| +1 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| +2 | K012445 | Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) | Electro Medical Systems SA | 2001 | 3 |
| +3 | K052135 | Cybersonics Cyberwand Dual Probe Lithotripter | Cybersonics, Inc. | 2005 | 1 |
| +3 | K173234 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018 | — |
| +4 | K102169 | Cyberwand Lithotripter | Cybersonics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963285 | Ems Swiss Lithoclast Lithotripter | 1997 | 22 |
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?
- Of its descendants, K963285 (Electro Medical Systems SA, 1997) has gone furthest, with 22 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.
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 | — |
https://510kreport.com/device/K913487 · printed Nov 5, 2026
Cite this page
510(k) Report. “K913487: Riwolith 2280.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K913487
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026