Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vasonova, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
141 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | Vasonova, Inc. | 2013-01-18 | 38 | 1 |
| K103260 | VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE | Vasonova, Inc. | 2011-02-18 | 106 | 0 |
| K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET | Vasonova, Inc. | 2011-02-18 | 107 | 2 |
| K091924 | VPS CATHETER | Vasonova, Inc. | 2009-11-18 | 141 | 0 |
| K083920 | FLOWPICC CATHETER | Vasonova, Inc. | 2009-05-01 | 121 | 0 |
| K082481 | FLOWPICC CATHETER | Vasonova, Inc. | 2008-12-17 | 111 | 0 |
| K081626 | FLOWPICC CONSOLE | Vasonova, Inc. | 2008-10-15 | 127 | 0 |
| K081625 | FLOWPICC STYLET | Vasonova, Inc. | 2008-09-26 | 108 | 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