Telstar Electronics, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Telstar Electronics, Inc.” (first 1987, latest 1989), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 49 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 | 10 | 10 |
| LRS | I.V. Start Kit | 1 | 1 |
Review panels
Most recent Telstar Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892460 | TELSTAR MODEL PP ITE HEARING AID | ESD | 1989-06-06 | 57 |
| K892459 | TELSTAR MODEL C ITE HEARING AID | ESD | 1989-06-06 | 57 |
| K892458 | TELSTAR MODEL F ITE HEARING AID | ESD | 1989-06-06 | 57 |
| K892457 | TELSTAR MODEL 1/3 ITE HEARING AID | ESD | 1989-06-06 | 57 |
| K871731 | TELSTAR PREWIRE SERIES | LRS | 1987-10-27 | 175 |
| K873210 | TELSTAR MODEL PP | ESD | 1987-09-29 | 46 |
| K871520 | TELSTAR MODEL FS HEARING AID | ESD | 1987-06-08 | 49 |
| K871522 | TELSTAR MODEL C HEARING AID | ESD | 1987-06-05 | 46 |
| K871521 | FULL SHELL ITE HEARING AID | ESD | 1987-06-05 | 46 |
| K871518 | TELSTAR MODEL F3TS HEARING AID | ESD | 1987-06-05 | 46 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Telstar Electronics, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Telstar Innovations, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Telstar Electronics, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Telstar Electronics, Inc.” (first 1987, latest 1989), across 2 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 Telstar Electronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Telstar Electronics, Inc. is 49 days.
Which FDA product codes appear under Telstar Electronics, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 10); LRS (I.V. Start Kit, 1).
Next steps
- See all 11 Telstar Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Telstar Electronics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.