Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vascular Architects, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
154 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031641 | VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SY | Vascular Architects, Inc. | 2003-08-01 | 66 | 0 |
| K030567 | MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND | Vascular Architects, Inc. | 2003-03-24 | 28 | 0 |
| K012544 | VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPA | Vascular Architects, Inc. | 2001-11-15 | 100 | 0 |
| K003173 | ASPIRE COVERED STENT AND DELIVERY CATHETER | Vascular Architects, Inc. | 2001-03-13 | 154 | 0 |
| K003719 | VASCULAR ARCHITECTS PERISCOPE DEVICE | Vascular Architects, Inc. | 2001-02-28 | 86 | 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