Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medel S.P.A. · 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) |
|---|---|---|---|---|---|
| K081463 | MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP | Medel S.P.A. | 2009-02-06 | 259 | 0 |
| K072494 | AG-CLASSIC | Medel S.P.A. | 2008-02-12 | 160 | 0 |
| K063103 | AG-EDGE, MODEL 91200 | Medel S.P.A. | 2007-01-08 | 90 | 0 |
| K060404 | AG-PLUS, MODEL 91210 | Medel S.P.A. | 2006-06-22 | 127 | 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