Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Biofire Defense, LLC — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

120 daysmedian FDA review time
526 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC2026-07-17730
K243822BioFire Warrior Panel; BioFire Warrior Panel Control KitBiofire Defense, LLC2025-03-12900
K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELDBiofire Defense, LLC2023-03-225260
K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for tBiofire Defense, LLC2022-10-202090
K221460BioFire COVID-19 Test 2Biofire Defense, LLC2022-07-25670
K211079BioFire COVID-19 Test 2Biofire Defense, LLC2021-11-012030
DEN200043FilmArray Global Fever PanelBiofire Defense, LLC2020-11-201470
K202382FilmArray Global Fever Panel External Control KitBiofire Defense, LLC2020-11-20920
K170883FilmArray NGDS Warrior PanelBiofire Defense, LLC2017-06-22903
DEN160048FilmArray NGDS Warrior PanelBiofire Defense, LLC2017-02-141200

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