Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Safety Razor Co. — 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) |
|---|---|---|---|---|---|
| K924503 | PERSONNA SAFETY SCALPEL | American Safety Razor Co. | 1993-02-05 | 154 | 0 |
| K873142 | PERSONNA DISPOSABLE SCALPEL | American Safety Razor Co. | 1987-09-04 | 25 | 0 |
| K863557 | BLADE, SURGICAL PREPARATION RAZOR, STRAIGHT,SINGLE | American Safety Razor Co. | 1986-10-06 | 24 | 0 |
| K771045 | BLADES, SCALPEL | American Safety Razor Co. | 1977-06-22 | 12 | 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