Venusa , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Venusa , Ltd.” (first 1981, latest 2000), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 70 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 | 5 | 5 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Venusa , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994429 | VENUSA, LTD. EXTENSION SET WITH FILTER | FPA | 2000-03-03 | 64 |
| K981683 | HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y | FPA | 1998-07-28 | 76 |
| K905518 | BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET | IZI | 1991-06-21 | 196 |
| K851975 | ENTERAL FEEDING BAG, 1000 ML, & TUBING SET | KNT | 1985-09-05 | 121 |
| K843692 | FLU VEN I.V. SET 0153-C PERMA-SET | FPA | 1984-10-31 | 42 |
| K842088 | FLU MET 2 | FPA | 1984-08-17 | 85 |
| K812981 | FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) | FPK | 1981-11-06 | 14 |
| K811914 | FLU VEN I.V. SETS | FPA | 1981-08-03 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named Venusa , Ltd..
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 Venusa , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Venusa , Ltd.” (first 1981, latest 2000), across 4 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 Venusa , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Venusa , Ltd. is 70 days.
Which FDA product codes appear under Venusa , Ltd.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 5); FPK (Tubing, Fluid Delivery, 1); IZI (System, X-Ray, Angiographic, 1).
Next steps
- See all 8 Venusa , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Venusa , Ltd.'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.