Vicon Instrument Co.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Vicon Instrument Co.” (first 1976, latest 1981), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 28 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 | 4 | 4 |
| KLW | Masker, Tinnitus | 2 | 2 |
| ETS | Generator, Electronic Noise (For Audiometric Testing) | 1 | 1 |
| EWO | Audiometer | 1 | 1 |
Review panels
Most recent Vicon Instrument Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K811751 | FINETONE MODEL VI HEARING AID | ESD | 1981-07-15 | 23 |
| K790878 | SCREENING AUDIOMETER, HIGH FREQUENCY | EWO | 1979-08-03 | 88 |
| K790064 | TINNITUS DEVICES | ETS | 1979-02-16 | 32 |
| K771769 | TINNITUS MASKERS, MODELS S564&S574 | KLW | 1978-01-03 | 106 |
| K771762 | MODULAR HEARING DEVICE, MODEL S291 | ESD | 1977-10-04 | 15 |
| K770938 | TINNITUS AID, MODEL S244 | KLW | 1977-06-28 | 36 |
| K761216 | HEARING AIDS (MODEL E-552 S-712) | ESD | 1976-12-16 | 9 |
| K760215 | HEARING AID, S-522 FM | ESD | 1976-07-21 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Vicon Instrument Co..
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 Vicon Instrument Co.?
FDA lists 8 510(k) clearances under the applicant name “Vicon Instrument Co.” (first 1976, latest 1981), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vicon Instrument Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vicon Instrument Co. is 28 days.
Which FDA product codes appear under Vicon Instrument Co.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 4); KLW (Masker, Tinnitus, 2); ETS (Generator, Electronic Noise (For Audiometric Testing), 1).
Next steps
- See all 8 Vicon Instrument Co. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Vicon Instrument Co.'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.