Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
R4 Vascular, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
232 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131329 | VECTOR PTA BALLOON DILATATION CATHETER | R4 Vascular, Inc. | 2013-06-06 | 29 | 0 |
| K121385 | VECTOR | R4 Vascular, Inc. | 2012-06-14 | 37 | 0 |
| K100169 | DURASPAN HEMODIALYSIS LONG-TERM CATHETER | R4 Vascular, Inc. | 2010-02-18 | 29 | 1 |
| K091506 | DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 6 | R4 Vascular, Inc. | 2010-01-08 | 232 | 1 |
| K092040 | PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 43010244 | R4 Vascular, Inc. | 2009-11-18 | 139 | 0 |
| K083763 | ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN | R4 Vascular, Inc. | 2009-03-16 | 88 | 0 |
| K071361 | R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, | R4 Vascular, Inc. | 2007-08-20 | 97 | 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