510(k) · Cleared
ClearedCyberwand Sterile Pads, Model: CW-Rbpbx
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 Oct 24, 2007 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Oct 24, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- FFK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK072422 Cyberwand Sterile Pads, Model: CW-RbpbxCybersonics, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK132795 Cyberwand Sterile Probe SetCybersonics, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132795Cyberwand Sterile Probe SetCybersonics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072422 | Cyberwand Sterile Pads, Model: CW-Rbpbx | Cybersonics, Inc. | 2007 | — |
| +1 | K132795 | Cyberwand Sterile Probe Set | Cybersonics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K132795 | Cyberwand Sterile Probe Set | 2013 | 0 |
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, K132795 (Cybersonics, Inc., 2013) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.
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 CyberWandTM Lithotripter with STERILE Probes is intended to be used for the intracorporeal fragmentation of urinary tract calculi in the kidney, ureter, bladder and biliary tracts.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K072422 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072422: Cyberwand Sterile Pads, Model: CW-Rbpbx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072422
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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