Beltone Electronics Corp.: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Beltone Electronics Corp.” (first 1980, latest 1997), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 64 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 | 36 | 36 |
| EWO | Audiometer | 5 | 5 |
| KLW | Masker, Tinnitus | 1 | 1 |
Review panels
- Ear, Nose and Throat (42)
Most recent Beltone Electronics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971852 | AIR CONDUCTION HAEARING AIDS | ESD | 1997-08-15 | 87 |
| K963958 | IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT | ESD | 1996-12-05 | 64 |
| K955930 | BELTONE COMPOSER 2000 BTE HP | ESD | 1996-03-01 | 71 |
| K954936 | BELTONE ULTIMA 80 OTOSONIC POWER PAS | ESD | 1995-12-06 | 40 |
| K943616 | BELTONE PERSONAL HEARING SCREENER | EWO | 1995-07-12 | 350 |
| K951587 | BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K | ESD | 1995-06-30 | 85 |
| K952097 | OTOSONIC (OSI) CF 10-K, 10-D | ESD | 1995-06-28 | 55 |
| K950868 | BELTONE COMPOSER 2000 | ESD | 1995-06-28 | 121 |
| K946340 | BELTONE COMPARAFIT | ESD | 1995-04-13 | 105 |
| K944502 | BELTONE CONCERTO S | ESD | 1994-10-20 | 36 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Beltone Electronics 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Beltone Electronics Corp.?
FDA lists 42 510(k) clearances under the applicant name “Beltone Electronics Corp.” (first 1980, latest 1997), across 3 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 Beltone Electronics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Beltone Electronics Corp. is 64 days.
Which FDA product codes appear under Beltone Electronics Corp.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 36); EWO (Audiometer, 5); KLW (Masker, Tinnitus, 1).
Next steps
- See all 42 Beltone Electronics Corp. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Beltone Electronics 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.