Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scion Cardio-Vascular, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112961 | CLO-SURPLUS P.A.D. | Scion Cardio-Vascular, Inc. | 2011-10-31 | 27 | 0 |
| K092552 | CLO-SURPLUS P.A.D. | Scion Cardio-Vascular, Inc. | 2009-09-04 | 15 | 0 |
| K052509 | M-BOLUS EMBOLIC MICROSPHERES | Scion Cardio-Vascular, Inc. | 2006-12-11 | 454 | 0 |
| K032986 | CLO-SURPLUSP.A.D. | Scion Cardio-Vascular, Inc. | 2004-03-01 | 159 | 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