Viratek, Inc.: FDA clearances and approvals
Viratek, Inc. has 5 FDA 510(k) clearances (first 1985, latest 1990), across 3 product codes in 1 review panel. Median 510(k) review time: 180 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 |
|---|---|---|---|
| BYL | Tent, Oxygen | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
Plus 1 more product codes.
Review panels
- Anesthesiology (4)
Most recent Viratek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896608 | SPAG PAK | BYL | 1990-04-09 | 139 |
| K882396 | AEROSOL DELIVERY HOOD | BYL | 1988-08-01 | 52 |
| K871427 | (SPAG) MODEL SPAG-2 6000 SERIES | CAF | 1987-10-06 | 180 |
| K870051 | SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE | CAF | 1987-10-06 | 273 |
| K843717 | VIRATEK SMALL PARTICLE AEROSOL GENERAT | — | 1985-12-30 | 465 |
Recalls
openFDA lists no recalls under a recalling firm named Viratek, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Viratek, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Viratek, Inc. have?
Viratek, Inc. has 5 FDA 510(k) clearances (first 1985, latest 1990), across 3 product codes in 1 review panel.
How long does FDA take to clear Viratek, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Viratek, Inc.'s cleared 510(k)s is 180 days.
What devices does Viratek, Inc. make?
Its most frequent FDA product codes are BYL (Tent, Oxygen, 2); CAF (Nebulizer (Direct Patient Interface), 2).
Has Viratek, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Viratek, Inc. Related entities may recall under other names.
Next steps
- See all 5 Viratek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BYL, Viratek, Inc.'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.