FDA applicant
Biofire Defense, LLC
FDA records 10 decisions for Biofire Defense, LLC (Salt Lake City, UT) from 2017 to 2026: 8 510(k) clearances and 2 De Novo grants. Most are in product codes PRD (Unnamed device) and PMN (Assayed External Control Material For…). Its devices cite 9 predicates, 7 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biofire Defense, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Biofire Defense, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Biofire”
FDA records each applicant name separately; these may or may not be the same firm.