Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medafor, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123325 | Medafor Direct Gas-Assisted Application System | Medafor, Inc. | 2013-01-24 | 90 | 0 |
| K033666 | HEMADERM | Medafor, Inc. | 2003-12-17 | 26 | 0 |
| K021678 | HEMADERM COTAINING HEMADEX CLOTTING BEADS | Medafor, Inc. | 2002-07-12 | 52 | 0 |
| K013225 | INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE | Medafor, Inc. | 2001-12-26 | 90 | 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