Vivosonic, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Vivosonic, Inc.” (first 2001, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 85 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 85 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vivosonic, Inc. took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | 3 | 3 |
| EWO | Audiometer | 2 | 2 |
Review panels
- Neurology (3)
- Ear, Nose and Throat (2)
Most recent Vivosonic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | GWJ | 2024-12-19 | 85 |
| K080060 | VIVOSONIC NEUROSCREEN | GWJ | 2008-04-04 | 86 |
| K043396 | INTEGRITY, MODEL V500 | GWJ | 2005-01-24 | 45 |
| K033108 | VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER | EWO | 2003-10-27 | 27 |
| K003364 | VIVO 200 DPS VIVOSCAN | EWO | 2001-07-18 | 264 |
Recalls
openFDA lists no recalls under a recalling firm named Vivosonic, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vivosonic, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Vivosonic, Inc.” (first 2001, latest 2024), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vivosonic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vivosonic, Inc. is 85 days.
Which FDA product codes appear under Vivosonic, Inc.?
The most frequent FDA product codes under this applicant name are GWJ (Stimulator, Auditory, Evoked Response, 3); EWO (Audiometer, 2).
Next steps
- See all 5 Vivosonic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWJ, Vivosonic, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.