Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Velano Vascular — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
879 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201237 | Velano Vascular Blood Collection Adapter | Velano Vascular | 2022-10-03 | 879 | 0 |
| K200439 | Velano ExT Extension Set | Velano Vascular | 2021-02-23 | 365 | 0 |
| K193569 | PIVO(TM) | Velano Vascular | 2020-01-21 | 29 | 0 |
| K190604 | PIVO | Velano Vascular | 2019-05-13 | 66 | 0 |
| K182897 | Velano Vascular Q2 Extension Set | Velano Vascular | 2019-03-26 | 161 | 0 |
| K163508 | PIVO | Velano Vascular | 2017-02-09 | 57 | 0 |
| K152924 | TIVA¿ | Velano Vascular | 2016-01-07 | 94 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda