Cleared Traditional

K243822 - BioFire Warrior Panel

Also marketed or referenced as:
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.

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FDA 510(k) Submission Details - K243822

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.

PRD Device Classification - Class ,

Product Code PRD
Device Class -