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FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics 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 Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics 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 Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / K262432

510(k) cleared

CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test

CorDx, Inc. · Oct 14, 2026 · K262432

FDA cleared the CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test from CorDx, Inc. on Oct 14, 2026 under K262432, a traditional 510(k). The device falls under product code SCA, Multi-Analyte Respiratory Virus Antigen Detection Test, regulated at 21 CFR 866.3987 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jul 16, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

CorDx, Inc. has one other decision in the tracker over the last 12 months: K253882 (CorDx Tyfast COVID-19 Ag Rapid Test Rx).

Questions & Answers

What did FDA clear under K262432?

K262432 is the FDA 510(k) for CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test, submitted by CorDx, Inc.. FDA's decision date was Oct 14, 2026, under product code SCA (Multi-Analyte Respiratory Virus Antigen Detection Test).

Who makes the CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test?

CorDx, Inc., based in Alpharetta, GA, is the applicant of record for K262432.

How long did the K262432 review take?

FDA received the submission on Jul 16, 2026 and issued its decision on Oct 14, 2026, 90 days later.

← All decisions in October 2026

Sources