510(k) · Cleared
Recalled · 2007Cybersonics Cyberwand Dual Probe Lithotripter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybersonics, Inc. · FFK Lithotriptor, Electro-Hydraulic
Cleared on Dec 20, 2005 as substantially equivalent to K012445 (Electro Medical Systems SA, 2001) and 1 other predicate after a 137-day review. Its family tree reaches back 3 generations to 1986. 6 later devices descend from it. It has been recalled once.
- Decided
- Dec 20, 2005
- Review
- 137 days
- Class
- Class II
- Product code
- FFK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K863642 (1986). 7 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
- 2 generations backK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- 1 generation backK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · Recalled
- This deviceK052135 Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK102169 Cyberwand LithotripterCybersonics, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK120303 Cyberwand Dual Action Ultrasonic Lithotripsy SystemCybersonics, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK142428 Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK171024 ShockPulse-SE Lithotripsy SystemCybersonics, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK132795 Cyberwand Sterile Probe SetCybersonics, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K102169Cyberwand LithotripterCybersonics, Inc. · 2010 · cites it directly5descendants
- K120303Cyberwand Dual Action Ultrasonic Lithotripsy SystemCybersonics, Inc. · 2012 · cites it directly3descendants
- K142428Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc. · 2014 · 2 generations on1descendant
- K171024ShockPulse-SE Lithotripsy SystemCybersonics, Inc. · 2017 · 3 generations on0descendants
- K132795Cyberwand Sterile Probe SetCybersonics, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863642 | Candela Model MDL-1 Laser Lithotriptor | Candela Corp. | 1986 | — |
| −2 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| −1 | K012445 | Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) | Electro Medical Systems SA | 2001 | 3 |
| 0 (this device) | K052135 | Cybersonics Cyberwand Dual Probe Lithotripter | Cybersonics, Inc. | 2005 | — |
| +1 | K102169 | Cyberwand Lithotripter | Cybersonics, Inc. | 2010 | — |
| +1 | K120303 | Cyberwand Dual Action Ultrasonic Lithotripsy System | Cybersonics, Inc. | 2012 | — |
| +2 | K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | Cybersonics, Inc. | 2014 | 1 |
| +3 | K171024 | ShockPulse-SE Lithotripsy System | Cybersonics, Inc. | 2017 | 6 |
| +2 | K132795 | Cyberwand Sterile Probe Set | Cybersonics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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) | 2001 |
| * | K973251 | Ksea CalcusonSummary page 2…Lithotripter is substantially equivalent to the Electro Medical Systems SA Swiss LithoClast Ultra (KO12445), and Karl Storz Calcuson Ultrasonic Lithotripter (K973251) which have been cleared for the percutaneous fragmentation and removal of kidney stones. Information on these system… | 1998 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2007 | Not classified | Z-1073-2007 | Other | Sterilization Instructions not adequate for sterilizing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K102169 (Cybersonics, Inc., 2010) has gone furthest, with 5 descendants of its own.
- 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.
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 Cyberwand Dual Probe Lithotripter is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.
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/K052135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052135: Cybersonics Cyberwand Dual Probe Lithotripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052135
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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