Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EBR · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925367 | A-DEC 7284 CUSPIDOR, CASCADE | A-Dec, Inc. | 1994-04-11 | 537 | 0 |
| K860058 | DENPAX | Nissho Iwai American Corp. | 1986-03-12 | 65 | 0 |
| K770600 | OROPHARYNGEAL SUCTION AIRWAY | W.H. Wall, D.D.S. | 1977-04-08 | 10 | 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