Gn Danavox, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Gn Danavox, Inc.” (first 1986, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 82 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 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 9 | 9 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 1 | 1 |
Review panels
- Ear, Nose and Throat (10)
Most recent Gn Danavox, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971032 | DANAVOX MODELS 163/162 BTE | ESD | 1997-06-17 | 88 |
| K971031 | AUDALLION III HEARING SYSTEM | ESD | 1997-06-17 | 88 |
| K942331 | DANAVOX MODEL CIC | ESD | 1994-11-15 | 183 |
| K924185 | DFS GENIUS BTE | ESD | 1992-11-03 | 75 |
| K905692 | 143 SERIES BTE | ESD | 1991-01-28 | 40 |
| K905679 | 133 SERIES BTE | ESD | 1991-01-28 | 40 |
| K896996 | CAS (COMPUTERIZED ANALYZER SYSTEM) | ETW | 1990-08-09 | 241 |
| K896995 | DISCRETION, IN THE CANAL HEARING INSTRUMENT | ESD | 1990-04-30 | 140 |
| K891594 | CERUMEN FILTER | ESD | 1989-05-10 | 51 |
| K863975 | CUSTOM IN-THE-EAR | ESD | 1986-11-07 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Gn Danavox, 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 Gn Danavox, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Gn Danavox, Inc.” (first 1986, latest 1997), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gn Danavox, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gn Danavox, Inc. is 82 days.
Which FDA product codes appear under Gn Danavox, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 9); ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 1).
Next steps
- See all 10 Gn Danavox, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Gn Danavox, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.