Vistek Corp.: FDA clearances and approvals
Vistek Corp. has 5 FDA 510(k) clearances (first 1984, latest 1990), across 5 product codes in 1 review panel. Median 510(k) review time: 64 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 |
|---|---|---|---|
| FTA | Light, Surgical, Accessories | 1 | 1 |
| FWG | Camera, Television, Endoscopic, With Audio | 1 | 1 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 1 | 1 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 1 | 1 |
| KQM | Camera, Surgical And Accessories | 1 | 1 |
Review panels
Most recent Vistek Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K904682 | VISTEK ELECTRONIC CONTROLLER | GEY | 1990-12-18 | 64 |
| K904681 | VLS 5300 300W XENON LIGHT SOURCE | HBI | 1990-12-18 | 64 |
| K871034 | LCA 2000 | FTA | 1987-04-10 | 24 |
| K860173 | VIS-2000 VIDEO SYSTEM | FWG | 1986-02-07 | 21 |
| K843806 | VIS-1000 VIDEO SYSTEM | KQM | 1984-12-12 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named Vistek Corp..
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 Vistek Corp. have?
Vistek Corp. has 5 FDA 510(k) clearances (first 1984, latest 1990), across 5 product codes in 1 review panel.
How long does FDA take to clear Vistek Corp.'s 510(k)s?
The median time from FDA receipt to decision across Vistek Corp.'s cleared 510(k)s is 64 days.
What devices does Vistek Corp. make?
Its most frequent FDA product codes are FTA (Light, Surgical, Accessories, 1); FWG (Camera, Television, Endoscopic, With Audio, 1); GEY (Motor, Surgical Instrument, Ac-Powered, 1).
Has Vistek Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Vistek Corp. Related entities may recall under other names.
Next steps
- See all 5 Vistek Corp. clearances with predicates and recalls
- Run predicate analysis for product code FTA, Vistek Corp.'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.