Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Safetec of America, 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) |
|---|---|---|---|---|---|
| K960048 | EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS | Safetec of America, Inc. | 1996-07-12 | 190 | 0 |
| K960073 | EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP | Safetec of America, Inc. | 1996-07-12 | 189 | 0 |
| K953461 | CPR MASK & RELATED FAMILY KITS | Safetec of America, Inc. | 1996-01-04 | 164 | 0 |
| K952962 | EZ-PERSONAL PROTECTION KIT | Safetec of America, Inc. | 1995-09-27 | 93 | 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