Vistech Consultants, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Vistech Consultants, Inc.” (first 1984, latest 1988), across 1 product code in 1 review panel. Median 510(k) review time under this name: 22 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 |
|---|---|---|---|
| HOX | Chart, Visual Acuity | 7 | 7 |
Review panels
- Ophthalmic (7)
Most recent Vistech Consultants, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882634 | VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE | HOX | 1988-07-15 | 18 |
| K881059 | MCT 8000 (MULTI-VISION CONTRAST TESTER) | HOX | 1988-04-04 | 24 |
| K881023 | VCTS 6500 SYSTEM | HOX | 1988-04-01 | 22 |
| K881022 | VCTS MARKETING PROGRAM SYSTEM | HOX | 1988-04-01 | 22 |
| K881021 | VCTS 700S SYSTEM | HOX | 1988-04-01 | 22 |
| K853481 | VISTECH VCTS GLARE TESTER | HOX | 1985-10-29 | 70 |
| K840255 | VISTECH VCTS 6000 | HOX | 1984-04-13 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Vistech Consultants, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vistech Consultants, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Vistech Consultants, Inc.” (first 1984, latest 1988), across 1 product code 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 Vistech Consultants, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vistech Consultants, Inc. is 22 days.
Which FDA product codes appear under Vistech Consultants, Inc.?
The most frequent FDA product codes under this applicant name are HOX (Chart, Visual Acuity, 7).
Next steps
- See all 7 Vistech Consultants, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HOX, Vistech Consultants, 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.