Venospital, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Venospital, Inc.” (first 1977, latest 1979), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 11 | 11 |
| KSB | Set, Transfer (Blood/Plasma) | 2 | 2 |
| FIE | Needle, Fistula | 1 | 1 |
Review panels
Most recent Venospital, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791131 | FLU VEN TR-1 | KSB | 1979-09-04 | 78 |
| K791130 | FLU-VEN TK-2 | KSB | 1979-09-04 | 78 |
| K790424 | FLU-VEN 01510 | FPA | 1979-04-30 | 60 |
| K790077 | BIOSTIL # 3884 | FPA | 1979-04-30 | 109 |
| K781190 | INFUSION SET, VENOTHIN 21 | FPA | 1978-08-10 | 27 |
| K781189 | FLU VEN 0151 | FPA | 1978-08-10 | 27 |
| K781188 | INFUSION SET, VENOTHIN 25 | FPA | 1978-08-10 | 27 |
| K781187 | INFUSION SET W/ INJECTION SITE, 23D-W | FPA | 1978-08-10 | 27 |
| K781186 | INFUSION, VENOTHIN 23 | FPA | 1978-08-10 | 27 |
| K781185 | INFUSION SET W/ INJECTION SITE | FPA | 1978-08-10 | 27 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Venospital, 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 Venospital, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Venospital, Inc.” (first 1977, latest 1979), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Venospital, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Venospital, Inc. is 30 days.
Which FDA product codes appear under Venospital, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 11); KSB (Set, Transfer (Blood/Plasma), 2); FIE (Needle, Fistula, 1).
Next steps
- See all 14 Venospital, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Venospital, 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, 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.