Electone, Inc.: FDA filings under this applicant name
FDA lists 73 510(k) clearances under the applicant name “Electone, Inc.” (first 1981, latest 1997), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 53 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 |
| LRB | Face Plate Hearing Aid | 9 | 9 |
| LRS | I.V. Start Kit | 1 | 1 |
Review panels
Most recent Electone, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973266 | Z DEQ-II | ESD | 1997-09-23 | 25 |
| K961084 | AM 400 | ESD | 1996-04-18 | 30 |
| K955702 | SONATA U-01 | ESD | 1996-02-22 | 69 |
| K953050 | Z33 | ESD | 1995-08-22 | 53 |
| K953047 | Z20 | ESD | 1995-08-22 | 53 |
| K953054 | AM 260 OHM | ESD | 1995-08-15 | 46 |
| K953053 | AM 260 PP | ESD | 1995-08-15 | 46 |
| K953052 | AM 260 K-AMP | ESD | 1995-08-15 | 46 |
| K953051 | Z35 | ESD | 1995-08-15 | 46 |
| K953049 | Z24 | ESD | 1995-08-15 | 46 |
63 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Electone, 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 Electone, Inc.?
FDA lists 73 510(k) clearances under the applicant name “Electone, Inc.” (first 1981, 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 Electone, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electone, Inc. is 53 days.
Which FDA product codes appear under Electone, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 63); LRB (Face Plate Hearing Aid, 9); LRS (I.V. Start Kit, 1).
Next steps
- See all 73 Electone, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Electone, 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.