Audiotone, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Audiotone, Inc.” (first 1987, latest 1988), across 1 product code in 1 review panel. Median 510(k) review time under this name: 29 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 | 12 | 12 |
Review panels
- Ear, Nose and Throat (12)
Most recent Audiotone, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881738 | AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID | ESD | 1988-05-13 | 21 |
| K881737 | AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID | ESD | 1988-05-13 | 21 |
| K881653 | AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID | ESD | 1988-05-13 | 28 |
| K881652 | AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID | ESD | 1988-05-11 | 26 |
| K880223 | MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID | ESD | 1988-03-14 | 54 |
| K880225 | MAGIC EAR MODEL CI IN-THE-EAR HEARING AID | ESD | 1988-03-09 | 49 |
| K880224 | MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AID | ESD | 1988-03-07 | 47 |
| K874384 | AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID | ESD | 1988-01-19 | 85 |
| K874385 | AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID | ESD | 1988-01-07 | 73 |
| K874323 | MODEL A-70, BEHIND-THE-EAR HEARING AID | ESD | 1987-11-20 | 30 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Audiotone, 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 Audiotone, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Audiotone, Inc.” (first 1987, latest 1988), across 1 product code 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 Audiotone, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Audiotone, Inc. is 29 days.
Which FDA product codes appear under Audiotone, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 12).
Next steps
- See all 12 Audiotone, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Audiotone, 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.