Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Safety Equipment Corp. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
22 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K801010 | KIRSCHNER WIRE | American Safety Equipment Corp. | 1980-05-20 | 22 | 0 |
| K771699 | CARA-STAIN MODEL 3000 | American Safety Equipment Corp. | 1977-09-13 | 7 | 0 |
| K760960 | SURGICAL WIRE DRIVER | American Safety Equipment Corp. | 1976-11-19 | 18 | 0 |
| K760956 | SURGICAL MICRO DRILL | American Safety Equipment Corp. | 1976-11-19 | 18 | 0 |
| K760958 | SURGICAL OSCILLATING SAW | American Safety Equipment Corp. | 1976-11-16 | 15 | 0 |
| K760957 | SURGICAL RECIPROCATING SAW | American Safety Equipment Corp. | 1976-11-15 | 14 | 0 |
| K760959 | SURGICAL CHISEL | American Safety Equipment Corp. | 1976-11-15 | 14 | 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