Trutone: FDA clearances and approvals
Trutone has 5 FDA 510(k) clearances (first 1997, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time: 30 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 | 4 | 4 |
| EWO | Audiometer | 1 | 1 |
Review panels
Most recent Trutone 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973377 | SIBELMED AC50D | EWO | 1998-03-10 | 183 |
| K972550 | AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC | ESD | 1997-07-31 | 31 |
| K972552 | AUDIFON H20 PC/AUDIFON H32 PP | ESD | 1997-07-30 | 30 |
| K972543 | TWIST PPAGC-1, TWIST PP | ESD | 1997-07-23 | 14 |
| K972542 | JAZZ PP AGC-O, JAZZ PP | ESD | 1997-07-23 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Trutone.
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 Trutone have?
Trutone has 5 FDA 510(k) clearances (first 1997, latest 1998), across 2 product codes in 1 review panel.
How long does FDA take to clear Trutone's 510(k)s?
The median time from FDA receipt to decision across Trutone's cleared 510(k)s is 30 days.
What devices does Trutone make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 4); EWO (Audiometer, 1).
Has Trutone had device recalls?
openFDA lists no recalls under a recalling firm name matching Trutone. Related entities may recall under other names.
Next steps
- See all 5 Trutone clearances with predicates and recalls
- Run predicate analysis for product code ESD, Trutone'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.