Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cybersonics, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
138 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171024 | ShockPulse-SE Lithotripsy System | Cybersonics, Inc. | 2017-08-21 | 138 | 5 |
| K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | Cybersonics, Inc. | 2014-11-13 | 76 | 0 |
| K132795 | CYBERWAND STERILE PROBE SET | Cybersonics, Inc. | 2013-11-26 | 81 | 0 |
| K120303 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | Cybersonics, Inc. | 2012-06-05 | 125 | 0 |
| K102169 | CYBERWAND LITHOTRIPTER | Cybersonics, Inc. | 2010-08-30 | 28 | 0 |
| K072422 | CYBERWAND STERILE PADS, MODEL: CW-RBPBX | Cybersonics, Inc. | 2007-10-24 | 57 | 0 |
| K052135 | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER | Cybersonics, Inc. | 2005-12-20 | 137 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda