Cleared Traditional

Visby Medical Flu and COVID-19 Test (K253971) - FDA 510(k) Clearance

K253971 · Visby Medical, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
May 2026
Decision
167d
Days
-
Risk

K253971 is an FDA 510(k) clearance for the Visby Medical Flu and COVID-19 Test.

Submitted by Visby Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on May 27, 2026 after a review of 167 days - an extended review cycle.

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 Visby Medical, Inc. devices

Submission Details

510(k) Number K253971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2025
Decision Date May 27, 2026
Days to Decision 167 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
65d slower than avg
Panel avg: 102d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SIA
Device Class -