Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GSZ · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K885110 | PROTEUS OX-19 IFA* | Investigacion Farmaceutica S.A. DE C.V. | 1989-08-15 | 246 | 0 |
| K760881 | FEBRILE ANTIGEN CONTROL SERA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-09 | 19 | 0 |
| K760097 | FEBRILE ANTIGENS & CONTROL SERUMS | Gamma Biologicals, Inc. | 1976-08-03 | 50 | 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