Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scientia Vascular, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
266 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260223 | Aristotle Mini Guidewire | Scientia Vascular, Inc. | 2026-08-06 | 192 | 0 |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular, Inc. | 2026-07-16 | 195 | 0 |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 | Scientia Vascular, Inc. | 2026-04-29 | 163 | 0 |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 | Scientia Vascular, Inc. | 2025-04-01 | 102 | 0 |
| K242301 | Socrates 38 Catheter | Scientia Vascular, Inc. | 2024-12-04 | 124 | 0 |
| K223913 | Socrates Aspiration System | Scientia Vascular, Inc. | 2023-09-20 | 265 | 1 |
| K223560 | Plato 17 Microcatheter | Scientia Vascular, Inc. | 2023-08-21 | 266 | 1 |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. | 2023-08-01 | 29 | 0 |
| K222437 | Aristotle Colossus Guidewire | Scientia Vascular, Inc. | 2023-01-26 | 167 | 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