Radioear Corp.: FDA clearances and approvals
Radioear Corp. has 14 FDA 510(k) clearances (first 1976, latest 1984), across 2 product codes in 1 review panel. Median 510(k) review time: 42 days.
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 | 13 | 13 |
Plus 1 more product codes.
Review panels
- Ear, Nose and Throat (13)
Most recent Radioear Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841934 | RADIOEAR M430 PP | ESD | 1984-09-07 | 119 |
| K841933 | RADIOEAR M420H | ESD | 1984-08-10 | 91 |
| K841475 | HEARING AID MODEL M400 | ESD | 1984-06-22 | 74 |
| K841474 | HEARING AID MODEL P500 | ESD | 1984-06-22 | 74 |
| K841473 | HEARING AID MODEL 440PPC | ESD | 1984-06-22 | 74 |
| K834523 | MODEL M410D HEARING AID | ESD | 1984-02-10 | 51 |
| K811522 | RE-HP SERIES HEARING AIDS | ESD | 1981-06-26 | 28 |
| K800945 | RADIOEAR MODEL REI HEARING AID | ESD | 1980-05-08 | 16 |
| K800567 | RADIOEAR MODEL RM-L & RM-C HEARING AID | ESD | 1980-04-29 | 47 |
| K800332 | RADIOEAR MODEL 2080 (HEARING AID) | ESD | 1980-03-05 | 20 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Radioear Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Radioear Corp. have?
Radioear Corp. has 14 FDA 510(k) clearances (first 1976, latest 1984), across 2 product codes in 1 review panel.
How long does FDA take to clear Radioear Corp.'s 510(k)s?
The median time from FDA receipt to decision across Radioear Corp.'s cleared 510(k)s is 42 days.
What devices does Radioear Corp. make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 13).
Has Radioear Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Radioear Corp. Related entities may recall under other names.
Next steps
- See all 14 Radioear Corp. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Radioear Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.