Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MOP · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980016 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-08-07 | 217 | 0 |
| K974648 | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | Sulzer Carbomedics, Inc. | 1998-08-04 | 235 | 0 |
| K960923 | CARBOMEDICS MITRAL ROTATOR | Carbomedics, Inc. | 1996-04-29 | 54 | 0 |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | Carbomedics, Inc. | 1995-06-20 | 85 | 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