Oticon Corp.: FDA filings under this applicant name
FDA lists 66 510(k) clearances under the applicant name “Oticon Corp.” (first 1978, latest 1997), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 28 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 | 63 | 63 |
| ERA | Otoscope | 2 | 2 |
| FSD | Binder, Abdominal | 1 | 1 |
Review panels
- Ear, Nose and Throat (65)
- General Hospital (1)
Most recent Oticon Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973886 | OTICON DIGISOUND COMPACT | ESD | 1997-11-04 | 21 |
| K973885 | OTICON DIGISOUND ITE | ESD | 1997-11-04 | 21 |
| K964683 | DIGIFOCUS ITE | ESD | 1996-12-12 | 20 |
| K963788 | PRIMOFOCUS COMPACT | ESD | 1996-11-27 | 68 |
| K961059 | DIGIFOCUS COMPACT | ESD | 1996-05-07 | 50 |
| K960284 | OTICON /PRIMOFOCUS (PF) | ESD | 1996-03-07 | 48 |
| K954794 | OTICON | ESD | 1995-11-13 | 26 |
| K950381 | OTICON/LOGIC | ESD | 1995-02-27 | 27 |
| K946045 | OTICON | ESD | 1995-01-30 | 49 |
| K933307 | MULTIFOCUS COMPACT BTE HEARING AID | ESD | 1993-08-23 | 47 |
56 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Oticon Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Oticon Medical AB (17 510(k)s)
- Oticon A/S (2 510(k)s)
- Oticon Medical (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oticon Corp.?
FDA lists 66 510(k) clearances under the applicant name “Oticon Corp.” (first 1978, latest 1997), across 3 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 Oticon Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oticon Corp. is 28 days.
Which FDA product codes appear under Oticon Corp.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 63); ERA (Otoscope, 2); FSD (Binder, Abdominal, 1).
Next steps
- See all 66 Oticon Corp. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Oticon Corp.'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.