Telesonic, Inc.: FDA clearances and approvals
Telesonic, Inc. has 12 FDA 510(k) clearances (first 1980, latest 1987), across 2 product codes in 2 review panels. Median 510(k) review time: 32 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 | 11 | 11 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
Most recent Telesonic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872606 | TELESONIC BODY STIMULATOR | IPF | 1987-12-22 | 173 |
| K813330 | POST-AURICULAR HEARING AID MODEL S-101 | ESD | 1982-01-19 | 56 |
| K813329 | POST-AURICULAR HEARING AID MODEL P-101 | ESD | 1982-01-19 | 56 |
| K813344 | POST-AURICULAR HEARING AID MODEL ASP-103 | ESD | 1981-12-31 | 36 |
| K813316 | CUSTOM-IN-THE-EAR HEARING AID | ESD | 1981-12-31 | 37 |
| K811031 | TELESONIC & ARCON | ESD | 1981-07-01 | 76 |
| K802597 | TELESONIC ARCON & SOUNDEX ASP 101 | ESD | 1980-11-12 | 22 |
| K802596 | TELESONIC, ARCON & SOUNDEX ASP 102 | ESD | 1980-11-12 | 22 |
| K801067 | TELESONIC, GENERIC & SOUNDEX C-102 | ESD | 1980-05-28 | 22 |
| K801066 | TELESONIC, SOUNDEX & GENERIC V-101 | ESD | 1980-05-28 | 22 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Telesonic, Inc..
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 Telesonic, Inc. have?
Telesonic, Inc. has 12 FDA 510(k) clearances (first 1980, latest 1987), across 2 product codes in 2 review panels.
How long does FDA take to clear Telesonic, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Telesonic, Inc.'s cleared 510(k)s is 32 days.
What devices does Telesonic, Inc. make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 11); IPF (Stimulator, Muscle, Powered, 1).
Has Telesonic, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Telesonic, Inc. Related entities may recall under other names.
Next steps
- See all 12 Telesonic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Telesonic, Inc.'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.