Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KAC · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901377 | BARTON-MAYO TRACHEOSTOMA BUTTON | Medical Innovations International, Inc. | 1990-06-14 | 84 | 0 |
| K873992 | LARYNGECTOMY TUBE | Portex, Inc. | 1988-03-24 | 175 | 0 |
| K821993 | SHILEY LARYNGECTOMY TUBE | Shiley, Inc. | 1982-08-12 | 36 | 0 |
| K811428 | NORTHWESTERN VOICE RESTORATION KIT | Universal Prosthetics, Inc. | 1981-06-16 | 25 | 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