Cybersonics, Inc.: FDA clearances and approvals
Cybersonics, Inc. has 7 FDA 510(k) clearances (first 2005, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time: 81 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 125 |
| 2013 | 1 | 81 |
| 2014 | 1 | 76 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 138 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cybersonics, Inc.'s cleared 510(k)s took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | 5 | 5 |
| FEO | Lithotriptor, Ultrasonic | 2 | 2 |
Review panels
Most recent Cybersonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171024 | ShockPulse-SE Lithotripsy System | FEO | 2017-08-21 | 138 |
| K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | FEO | 2014-11-13 | 76 |
| K132795 | CYBERWAND STERILE PROBE SET | FFK | 2013-11-26 | 81 |
| K120303 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | FFK | 2012-06-05 | 125 |
| K102169 | CYBERWAND LITHOTRIPTER | FFK | 2010-08-30 | 28 |
| K072422 | CYBERWAND STERILE PADS, MODEL: CW-RBPBX | FFK | 2007-10-24 | 57 |
| K052135 | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER | FFK | 2005-12-20 | 137 |
Recalls
openFDA lists no recalls under a recalling firm named Cybersonics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cybersonics, Inc. have?
Cybersonics, Inc. has 7 FDA 510(k) clearances (first 2005, latest 2017), across 2 product codes in 1 review panel.
How long does FDA take to clear Cybersonics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cybersonics, Inc.'s cleared 510(k)s is 81 days.
What devices does Cybersonics, Inc. make?
Its most frequent FDA product codes are FFK (Lithotriptor, Electro-Hydraulic, 5); FEO (Lithotriptor, Ultrasonic, 2).
Has Cybersonics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cybersonics, Inc. Related entities may recall under other names.
Next steps
- See all 7 Cybersonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FFK, Cybersonics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.