Cleared Traditional

Xpert Hemorrhagic Fever

K253653 · Cepheid · Microbiology

Feb 2026

Decision

92d

Days

—

Risk

About This 510(k) Submission

K253653 is an FDA 510(k) clearance for the Xpert Hemorrhagic Fever, submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on February 20, 2026, 92 days after receiving the submission on November 20, 2025. This device falls under the Microbiology review panel.

Submission Details

510(k) Number	K253653 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2025
Decision Date	February 20, 2026
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF