WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / September 2026 / K263035

510(k) cleared

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)

Centers for Disease Control and Prevention · Sep 30, 2026 · K263035

FDA cleared the CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) from Centers for Disease Control and Prevention on Sep 30, 2026 under K263035, a special 510(k). The device falls under product code OZE, Influenza A And Influenza B Multiplex Nucleic Acid Assay, regulated at 21 CFR 866.3980 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Aug 31, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Centers for Disease Control and Prevention has 2 other decisions in the tracker over the last 12 months: K262368 (B. anthracis Real-time PCR Assay), K260812 (Francisella tularensis Real-time PCR Assay).

Questions & Answers

What did FDA clear under K263035?

K263035 is the FDA 510(k) for CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit), submitted by Centers for Disease Control and Prevention. FDA's decision date was Sep 30, 2026, under product code OZE (Influenza A And Influenza B Multiplex Nucleic Acid Assay).

Who makes the CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)?

Centers for Disease Control and Prevention, based in Atlanta, GA, is the applicant of record for K263035.

How long did the K263035 review take?

FDA received the submission on Aug 31, 2026 and issued its decision on Sep 30, 2026, 30 days later.

← All decisions in September 2026

Sources