Velano Vascular: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Velano Vascular” (first 2015, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 66 days, against 223 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 1 | 90 |
| 2016 | 1 | 94 |
| 2017 | 1 | 57 |
| 2018 | 0 | — |
| 2019 | 2 | 114 |
| 2020 | 1 | 29 |
| 2021 | 1 | 365 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Velano Vascular took a median 66 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 5 | 5 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
Review panels
Most recent Velano Vascular 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200439 | Velano ExT Extension Set | FPA | 2021-02-23 | 365 |
| K193569 | PIVO(TM) | JKA | 2020-01-21 | 29 |
| K190604 | PIVO | JKA | 2019-05-13 | 66 |
| K182897 | Velano Vascular Q2 Extension Set | FPA | 2019-03-26 | 161 |
| K163508 | PIVO | JKA | 2017-02-09 | 57 |
| K152924 | TIVA¿ | JKA | 2016-01-07 | 94 |
| K142946 | TIVA | JKA | 2015-01-08 | 90 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2021-11-10.
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.
Device clinical trials
An industry sponsor named Velano Vascular is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02747147: Multi-Day Evaluation of the TIVA Device (Completed, started 2016-04-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Velano Vascular?
FDA lists 7 510(k) clearances under the applicant name “Velano Vascular” (first 2015, latest 2021), across 2 product codes in 2 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 Velano Vascular?
The median time from FDA receipt to decision across 510(k)s cleared under the name Velano Vascular is 90 days. Since 2017: 66 days, versus 223 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Velano Vascular?
The most frequent FDA product codes under this applicant name are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 5); FPA (Set, Administration, Intravascular, 2).
Next steps
- See all 7 Velano Vascular clearances with predicates and recalls
- Run predicate analysis for product code JKA, Velano Vascular'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.