Telex Communications, Inc.: FDA clearances and approvals
Telex Communications, Inc. has 50 FDA 510(k) clearances (first 1979, latest 1999), across 4 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 | 39 | 39 |
| EPF | Hearing Aid, Group And Auditory Trainer | 7 | 7 |
| LRB | Face Plate Hearing Aid | 3 | 3 |
| KLW | Masker, Tinnitus | 1 | 1 |
Review panels
- Ear, Nose and Throat (50)
Most recent Telex Communications, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984243 | TELEX TINNITUS-COMPANION | KLW | 1999-01-21 | 55 |
| K982683 | TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION | EPF | 1998-10-06 | 67 |
| K964639 | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II | ESD | 1997-01-21 | 63 |
| K963915 | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION | ESD | 1996-11-08 | 39 |
| K961143 | TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 | ESD | 1996-05-07 | 47 |
| K954579 | TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION | ESD | 1995-12-08 | 67 |
| K943961 | THE MODEL ACAPPELLA IN THE EAR HEARING AID | ESD | 1995-05-15 | 273 |
| K935048 | ARTISAN PROGRAMMER & HEARING AID | LRB | 1994-02-09 | 111 |
| K935366 | BINAURAL HEARING AID | ESD | 1994-01-13 | 70 |
| K933579 | MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID | ESD | 1993-08-23 | 31 |
40 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Telex Communications, 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 Telex Communications, Inc. have?
Telex Communications, Inc. has 50 FDA 510(k) clearances (first 1979, latest 1999), across 4 product codes in 1 review panel.
How long does FDA take to clear Telex Communications, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Telex Communications, Inc.'s cleared 510(k)s is 42 days.
What devices does Telex Communications, Inc. make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 39); EPF (Hearing Aid, Group And Auditory Trainer, 7); LRB (Face Plate Hearing Aid, 3).
Has Telex Communications, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Telex Communications, Inc. Related entities may recall under other names.
Next steps
- See all 50 Telex Communications, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Telex Communications, 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.