Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GRC · 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) |
|---|---|---|---|---|---|
| K905306 | MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN | Virion (U.S.), Inc. | 1991-06-17 | 201 | 0 |
| K832873 | MUMPS COMPLEMENT FIXATION & HEMAGGLU | Hazleton Dutchland, Inc. | 1983-12-27 | 124 | 0 |
| K802933 | MUMPS S & V ANTIGENS & CONTROLS | Orion Diagnostica, Inc. | 1980-12-31 | 42 | 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