Cleared Traditional

K243822 - BioFire Warrior Panel (FDA 510(k) Clearance)

Also includes:
BioFire Warrior Panel Control Kit
K243822 · Biofire Defense, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
90d
Days
-
Risk

K243822 is an FDA 510(k) clearance for the BioFire Warrior Panel.

Submitted by Biofire Defense, LLC (Salt Lake City, US). The FDA issued a Cleared decision on March 12, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biofire Defense, LLC devices

Submission Details

510(k) Number K243822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2024
Decision Date March 12, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PRD
Device Class -