Cleared Traditional

K253971 - Visby Medical Flu and COVID-19 Test

K253971 · Visby Medical, Inc. · Microbiology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K253971

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.

SIA Device Classification - Class ,

Product Code SIA
Device Class -