Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Corcym S.r.l. · 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) |
|---|---|---|---|---|---|
| K261707 | MEMO 4D Curve™ Semirigid mitral annuloplasty ring | Corcym S.r.l. | 2026-06-18 | 27 | 0 |
| K260498 | TriMemo™ SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | 2026-04-14 | 60 | 0 |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirig | Corcym S.r.l. | 2023-04-07 | 60 | 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