Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sapimed S.P.A. — 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) |
|---|---|---|---|---|---|
| K070881 | LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 | Sapimed S.P.A. | 2007-09-26 | 180 | 0 |
| K070913 | SELF-LIGHT DISPOSABLE ANOSCOPE | Sapimed S.P.A. | 2007-08-10 | 130 | 0 |
| K070915 | SAPIMED DISPOSABLE SIGMOIDOSCOPE | Sapimed S.P.A. | 2007-07-06 | 95 | 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