Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OPL · 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) |
|---|---|---|---|---|---|
| K212769 | DYNEX SmartPLEX MMRV IgG Assay Kit | Dynex Technologies, Inc. | 2023-09-29 | 759 | 0 |
| K111072 | BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETEC | Bio-Rad Laboratories | 2011-08-23 | 127 | 0 |
| K091616 | BIOPLEX 2200 MMRV IGG | Bio-Rad Laboratories | 2010-03-29 | 299 | 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