Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FFD · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874410 | CUMEVAC | Cumes-Honikman Partnership | 1987-12-03 | 36 | 0 |
| K760793 | ADAPTER FOR ELLIK EVACUATOR | V. Mueller O.V. Baxter Healthcare Corp. | 1976-10-15 | 8 | 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