Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GRA · 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) |
|---|---|---|---|---|---|
| K894624 | MUMPS VIRUS | Bion Ent., Ltd. | 1989-10-16 | 88 | 0 |
| K822826 | ANTIBODY TO MUMPS VIRUS IFA TEST | Electro-Nucleonics Laboratories, Inc. | 1982-12-03 | 73 | 0 |
| K770216 | VIRAL ANTISERA, FLUORESCEIN LABELED | Flow Laboratories, Inc. | 1977-03-01 | 27 | 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