510(k) · Cleared
Recalled · Class II · 2020Shock Pulse-SE Lithotripsy System CYBERWAND II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybersonics, Inc. · FEO Lithotriptor, Ultrasonic
Cleared on Nov 13, 2014 as substantially equivalent to K120303 (Cybersonics, Inc., 2012) after a 76-day review. Its family tree reaches back 6 generations to 1986. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 13, 2014
- Review
- 76 days
- Class
- Class II
- Product code
- FEO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K863642 (1986). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
- 5 generations backK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- 4 generations backK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · Recalled
- 3 generations backK052135 Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · Recalled
- 2 generations backK102169 Cyberwand LithotripterCybersonics, Inc. · 2010
- 1 generation backK120303 Cyberwand Dual Action Ultrasonic Lithotripsy SystemCybersonics, Inc. · 2012
- This deviceK142428 Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK171024 ShockPulse-SE Lithotripsy SystemCybersonics, Inc. · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K171024ShockPulse-SE Lithotripsy SystemCybersonics, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K863642 | Candela Model MDL-1 Laser Lithotriptor | Candela Corp. | 1986 | — |
| −5 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| −4 | 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 |
| −2 | K102169 | Cyberwand Lithotripter | Cybersonics, Inc. | 2010 | — |
| −1 | K120303 | Cyberwand Dual Action Ultrasonic Lithotripsy System | Cybersonics, Inc. | 2012 | — |
| 0 (this device) | K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | Cybersonics, Inc. | 2014 | — |
| +1 | K171024 | ShockPulse-SE Lithotripsy System | Cybersonics, Inc. | 2017 | 6 |
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 |
|---|---|---|
| 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 FEO? 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 FEO device
- #1 K230893 Swiss LthoClast Trilogyscore 8.3 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K120303 | Cyberwand Dual Action Ultrasonic Lithotripsy SystemSummary page 5…escribed in this Traditional 510(k) Submission is, in our opinion, substantially equivalent to the predicate device, CyberWand Dual Action Ultrasonic Lithotripsy System (K120303). Product Description The ShockPulse-SE Lithotripsy System (CYBERWAND II) is the next generation of the CyberWand System. The… | 2012 |
| † | K111058 | Uretron Model Urt | 2012 |
| † | K132795 | Cyberwand Sterile Probe Set | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171024 | ShockPulse-SE Lithotripsy System | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2020 | Class II | Z-2197-2020 | Component design/selection | A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K171024 (Cybersonics, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120303.
How does its category compare?
All FEO devicesFEO Lithotriptor, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ShockPulse-SE Lithotripsy System 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/K142428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142428: Shock Pulse-SE Lithotripsy System CYBERWAND II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142428
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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