Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PLO · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | QIAGEN GmbH | 2024-10-29 | 90 | 0 |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | Diasorin Molecular, LLC | 2019-05-13 | 98 | 1 |
| K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with Fi | Biofire Diagnostics, LLC | 2016-03-17 | 27 | 0 |
| DEN150013 | FilmArray Meningitis/Encephalitis(ME) Panel | Biofire Diagnostics, LLC | 2015-10-08 | 182 | 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