510(k) · Cleared
Recalled · Class II · 2026ShockPulse-SE Lithotripsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybersonics, Inc. · FEO Lithotriptor, Ultrasonic
Cleared on Aug 21, 2017 as substantially equivalent to K142428 (Cybersonics, Inc., 2014) after a 138-day review. Its family tree reaches back 7 generations to 1986. It has been recalled 6 times.
- Decided
- Aug 21, 2017
- Review
- 138 days
- Class
- Class II
- Product code
- FEO
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 7 generations to K863642 (1986). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
- 6 generations backK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- 5 generations backK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · Recalled
- 4 generations backK052135 Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · Recalled
- 3 generations backK102169 Cyberwand LithotripterCybersonics, Inc. · 2010
- 2 generations backK120303 Cyberwand Dual Action Ultrasonic Lithotripsy SystemCybersonics, Inc. · 2012
- 1 generation backK142428 Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc. · 2014 · Recalled
- This deviceK171024 ShockPulse-SE Lithotripsy SystemCybersonics, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K863642 | Candela Model MDL-1 Laser Lithotriptor | Candela Corp. | 1986 | — |
| −6 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| −5 | K012445 | Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) | Electro Medical Systems SA | 2001 | 3 |
| −4 | K052135 | Cybersonics Cyberwand Dual Probe Lithotripter | Cybersonics, Inc. | 2005 | 1 |
| −3 | K102169 | Cyberwand Lithotripter | Cybersonics, Inc. | 2010 | — |
| −2 | K120303 | Cyberwand Dual Action Ultrasonic Lithotripsy System | Cybersonics, Inc. | 2012 | — |
| −1 | K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | Cybersonics, Inc. | 2014 | 1 |
| 0 (this device) | K171024 | ShockPulse-SE Lithotripsy System | Cybersonics, Inc. | 2017 | — |
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 |
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 |
|---|---|---|---|
| * | K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND IISummary page 4…er, Ultrasonic Intracorporeal Predicate Devices Predicate Device ShockPulse-SE Lithotripsy System (K142428) 2… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2026 | Class II | Z-1494-2026 | Device Design | Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the… |
| Nov 14, 2025 | Class II | Z-1479-2026 | Device Design | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues. |
| Nov 14, 2025 | Class II | Z-1478-2026 | Device Design | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues. |
| Nov 14, 2025 | Class II | Z-1477-2026 | Device Design | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues. |
| Oct 8, 2025 | Class II | Z-0452-2026 | Device Design | The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during… |
| Jul 7, 2022 | Class II | Z-1514-2022 | Process change control | Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 11 ancestors have a recall of any class.
How does its category compare?
All FEO devicesFEO Lithotriptor, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
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/K171024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171024: ShockPulse-SE Lithotripsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171024
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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