Viggo Products: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Viggo Products” (first 1985, latest 1985), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 4 | 4 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Viggo Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850769 | VIGGO ACCESSORIES FOR I.V. THERAPY | FPA | 1985-05-29 | 93 |
| K850277 | VIGGO I.V. ACCESSORIES-VIGGO EXTENSION TUBES ETC. | FPA | 1985-04-12 | 79 |
| K850276 | VIGGO NEOFLON INFUSION CANNULA | FOZ | 1985-04-12 | 79 |
| K850460 | VIGGO SECALON T CATHETER | FOZ | 1985-04-11 | 64 |
| K850280 | VIGGO CONNECTA 3-WAY INFUSION STOPCOCK | FMG | 1985-04-11 | 78 |
| K850349 | VIGGO ARTERIAL CANNULA | FOZ | 1985-04-09 | 71 |
| K850278 | VASCULON I.V. CANNULAE | FOZ | 1985-04-09 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named Viggo Products.
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 Viggo Products?
FDA lists 7 510(k) clearances under the applicant name “Viggo Products” (first 1985, latest 1985), across 3 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 Viggo Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viggo Products is 78 days.
Which FDA product codes appear under Viggo Products?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 4); FPA (Set, Administration, Intravascular, 2); FMG (Stopcock, I.V. Set, 1).
Next steps
- See all 7 Viggo Products clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Viggo Products'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.