Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vesalio, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
219 daysmedian FDA review time
271 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254211 | pVasc Net Mechanical Thrombectomy Device | Vesalio, Inc. | 2026-08-05 | 219 | 0 |
| K251097 | V-DAC Catheter | Vesalio, Inc. | 2026-01-06 | 271 | 0 |
| K253407 | NeVa PV Thrombectomy Device | Vesalio, Inc. | 2025-11-24 | 55 | 0 |
| K251006 | NeVasc Aspiration System | Vesalio, Inc. | 2025-11-10 | 223 | 0 |
| K251312 | Vesalio Peripheral System | Vesalio, Inc. | 2025-10-24 | 179 | 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