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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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.

Visby Medical, Inc. has one other decision in the tracker over the last 12 months: K251501 (Visby Medical Men's Sexual Health Test).

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

Sources