Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cox Sterile Products, 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) |
|---|---|---|---|---|---|
| K922440 | STERIKING, SEE & PEEL | Cox Sterile Products, Inc. | 1994-09-26 | 857 | 0 |
| K910925 | DISINFECTION WITH THE COX DRY HEAT STERILIZER | Cox Sterile Products, Inc. | 1992-05-08 | 430 | 0 |
| K881371 | COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE | Cox Sterile Products, Inc. | 1988-04-13 | 12 | 0 |
| K872643 | COX RAPID HEAT TRANSFER STERILIZER | Cox Sterile Products, Inc. | 1987-10-29 | 115 | 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