Bernafon-Maico, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Bernafon-Maico, Inc.” (first 1996, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 48 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 | 5 | 5 |
| EWO | Audiometer | 4 | 4 |
Review panels
Most recent Bernafon-Maico, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982723 | MAICO MA42 | EWO | 1998-10-28 | 84 |
| K981142 | MAICO MA53 | EWO | 1998-04-22 | 23 |
| K974211 | OPUS 2 - FULL CONCHA SERIES - ITE | ESD | 1997-12-15 | 35 |
| K974152 | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | ESD | 1997-12-15 | 41 |
| K974069 | OPUS 2 - CANAL SERIES (ITC) | ESD | 1997-12-15 | 48 |
| K973948 | DUALINE 100 BTE | ESD | 1997-10-28 | 12 |
| K971158 | DUALINE 400 CIC | ESD | 1997-06-13 | 77 |
| K971080 | MAICO MA52 | EWO | 1997-06-06 | 73 |
| K962275 | MAICO MA25 SERIES II WITH SPEECH | EWO | 1996-09-05 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Bernafon-Maico, 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 Bernafon-Maico, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Bernafon-Maico, Inc.” (first 1996, latest 1998), 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 Bernafon-Maico, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bernafon-Maico, Inc. is 48 days.
Which FDA product codes appear under Bernafon-Maico, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 5); EWO (Audiometer, 4).
Next steps
- See all 9 Bernafon-Maico, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Bernafon-Maico, 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.