510(k) · Cleared
ClearedKsea Calcuson
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FEO Lithotriptor, Ultrasonic
Cleared on Jun 22, 1998 after a 297-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Jun 22, 1998
- Review
- 297 days
- Class
- Class II
- Product code
- FEO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK973251 Ksea CalcusonKARL STORZ Endoscopy-America, Inc. · 1998
- Descendant · cites it directly · 6 of its ownK052135 Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 5 of its ownK102169 Cyberwand LithotripterCybersonics, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK120303 Cyberwand Dual Action Ultrasonic Lithotripsy SystemCybersonics, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK142428 Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 0 of its ownK171024 ShockPulse-SE Lithotripsy SystemCybersonics, Inc. · 2017 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052135Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · cites it directly6descendants
- K102169Cyberwand LithotripterCybersonics, Inc. · 2010 · 2 generations on5descendants
- K120303Cyberwand Dual Action Ultrasonic Lithotripsy SystemCybersonics, Inc. · 2012 · 2 generations on3descendants
- K142428Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc. · 2014 · 3 generations on1descendant
- K171024ShockPulse-SE Lithotripsy SystemCybersonics, Inc. · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973251 | Ksea Calcuson | KARL STORZ Endoscopy-America, Inc. | 1998 | — |
| +1 | K052135 | Cybersonics Cyberwand Dual Probe Lithotripter | Cybersonics, Inc. | 2005 | 1 |
| +2 | K102169 | Cyberwand Lithotripter | Cybersonics, Inc. | 2010 | — |
| +2 | K120303 | Cyberwand Dual Action Ultrasonic Lithotripsy System | Cybersonics, Inc. | 2012 | — |
| +3 | K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | Cybersonics, Inc. | 2014 | 1 |
| +4 | K171024 | ShockPulse-SE Lithotripsy System | Cybersonics, Inc. | 2017 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 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?
The FDA summary names no predicate by number.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052135 | Cybersonics Cyberwand Dual Probe Lithotripter | 2005 | 6 |
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, K052135 (Cybersonics, Inc., 2005) has gone furthest, with 6 descendants of its own.
How does its category compare?
All FEO devicesFEO Lithotriptor, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
These instruments are intended for use by qualified surgeons and provide for the fragmentation of renal, ureteral and bladder calculi.
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/K973251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973251: Ksea Calcuson.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973251
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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