Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Entravision, Inc. — 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) |
|---|---|---|---|---|---|
| K870775 | ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE | Entravision, Inc. | 1987-03-26 | 28 | 0 |
| K862064 | ENTRAVISION EP-500 I/A ECCO PACK | Entravision, Inc. | 1986-06-19 | 20 | 0 |
| K862063 | ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE | Entravision, Inc. | 1986-06-19 | 20 | 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