Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QMV · 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) |
|---|---|---|---|---|---|
| K243463 | BIOFIRE FILMARRAY Tropical Fever Panel | Biofire Diagnostics, LLC (Biomerieux) | 2024-12-05 | 27 | 0 |
| K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for t | Biofire Defense, LLC | 2022-10-20 | 209 | 0 |
| DEN200043 | FilmArray Global Fever Panel | Biofire Defense, LLC | 2020-11-20 | 147 | 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