Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GSN · 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) |
|---|---|---|---|---|---|
| K952145 | SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM | Sa Scientific, Inc. | 1995-07-18 | 71 | 0 |
| K885113 | IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL | Investigacion Farmaceutica S.A. DE C.V. | 1989-08-15 | 246 | 0 |
| K791385 | NEGATIVE CONTROL SERUM FOR CF RO ID | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 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