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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 / October 2026 / K262368

510(k) cleared

B. anthracis Real-time PCR Assay

Centers for Disease Control and Prevention · Oct 7, 2026 · K262368

FDA cleared the B. anthracis Real-time PCR Assay from Centers for Disease Control and Prevention on Oct 7, 2026 under K262368, a traditional 510(k). The device falls under product code NHT, Assay, Nucleic Acid Amplification, Bacillus Anthracis, regulated at 21 CFR 866.3045 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jul 10, 2026. The decision came 89 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: K263035 (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)), K260812 (Francisella tularensis Real-time PCR Assay).

Questions & Answers

What did FDA clear under K262368?

K262368 is the FDA 510(k) for B. anthracis Real-time PCR Assay, submitted by Centers for Disease Control and Prevention. FDA's decision date was Oct 7, 2026, under product code NHT (Assay, Nucleic Acid Amplification, Bacillus Anthracis).

Who makes the B. anthracis Real-time PCR Assay?

Centers for Disease Control and Prevention, based in Atlanta, GA, is the applicant of record for K262368.

How long did the K262368 review take?

FDA received the submission on Jul 10, 2026 and issued its decision on Oct 7, 2026, 89 days later.

← All decisions in October 2026

Sources