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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / May 2026 / K253971

510(k) cleared

Visby Medical Flu and COVID-19 Test

Visby Medical, Inc. · May 27, 2026 · K253971

FDA cleared the Visby Medical Flu and COVID-19 Test from Visby Medical, Inc. on May 27, 2026 under K253971, a traditional 510(k). The device falls under product code SIA, Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test, regulated at 21 CFR 866.3984 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 11, 2025. The decision came 167 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Visby Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253971?

K253971 is the FDA 510(k) for Visby Medical Flu and COVID-19 Test, submitted by Visby Medical, Inc.. FDA's decision date was May 27, 2026, under product code SIA (Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test).

Who makes the Visby Medical Flu and COVID-19 Test?

Visby Medical, Inc., based in San Jose, CA, is the applicant of record for K253971.

How long did the K253971 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on May 27, 2026, 167 days later.

← All decisions in May 2026