Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Epitek, 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) |
|---|---|---|---|---|---|
| K080780 | ANCHORAGE SCOPE, MODEL 000003 | Epitek, Inc. | 2008-07-30 | 133 | 0 |
| K073507 | ANCHORAGE ACCESS KIT | Epitek, Inc. | 2008-03-05 | 83 | 0 |
| K073096 | ANCHORAGE CLOSURE DEVICE | Epitek, Inc. | 2008-02-07 | 98 | 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