Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Velocimed, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
358 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052523 | PROXIS SYSTEM | Velocimed, Inc. | 2006-09-07 | 358 | 0 |
| K043084 | PREMERE DELIVERY SHEATH, MODEL PDS | Velocimed, Inc. | 2005-05-02 | 175 | 0 |
| K042117 | PROXIS SYSTEM, MODEL EPS 101 | Velocimed, Inc. | 2005-01-07 | 155 | 0 |
| K042910 | VENTURE WIRE CONTROL CATHETER, MODEL WCC | Velocimed, Inc. | 2004-11-22 | 32 | 1 |
| K040922 | VENTURE WIRE CONTROL CATHETER | Velocimed, Inc. | 2004-08-18 | 132 | 1 |
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