Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Heart Valves — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052970 | SIMPLICI-T ANNULOPLASTY SYSTEM | Medtronic Heart Valves | 2006-01-11 | 79 | 0 |
| K052860 | CG FUTURE ANNULOPLASTY BAND | Medtronic Heart Valves | 2005-11-10 | 30 | 0 |
| K032810 | DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAN | Medtronic Heart Valves | 2003-12-05 | 87 | 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