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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 / June 2026 / K253882

510(k) cleared

CorDx Tyfast COVID-19 Ag Rapid Test Rx

CorDx, Inc. · Jun 1, 2026 · K253882

FDA cleared the CorDx Tyfast COVID-19 Ag Rapid Test Rx from CorDx, Inc. on Jun 1, 2026 under K253882, a dual track 510(k). The device falls under product code QVF, Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings, regulated at 21 CFR 866.3982 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 4, 2025. The decision came 179 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 CorDx, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253882?

K253882 is the FDA 510(k) for CorDx Tyfast COVID-19 Ag Rapid Test Rx, submitted by CorDx, Inc.. FDA's decision date was Jun 1, 2026, under product code QVF (Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings).

Who makes the CorDx Tyfast COVID-19 Ag Rapid Test Rx?

CorDx, Inc., based in Alpharetta, GA, is the applicant of record for K253882.

How long did the K253882 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on Jun 1, 2026, 179 days later.

← All decisions in June 2026