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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 / March 2026 / K260812

510(k) cleared

Francisella tularensis Real-time PCR Assay

Centers for Disease Control and Prevention · Mar 30, 2026 · K260812

FDA cleared the Francisella tularensis Real-time PCR Assay from Centers for Disease Control and Prevention on Mar 30, 2026 under K260812, a special 510(k). The device falls under product code SGA, Biothreat Microbial Agent Nucleic Acid Detection Test, regulated at 21 CFR 866.4000 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Mar 13, 2026. The decision came 17 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), 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)).

Questions & Answers

What did FDA clear under K260812?

K260812 is the FDA 510(k) for Francisella tularensis Real-time PCR Assay, submitted by Centers for Disease Control and Prevention. FDA's decision date was Mar 30, 2026, under product code SGA (Biothreat Microbial Agent Nucleic Acid Detection Test).

Who makes the Francisella tularensis Real-time PCR Assay?

Centers for Disease Control and Prevention, based in Atlanta, GA, is the applicant of record for K260812.

How long did the K260812 review take?

FDA received the submission on Mar 13, 2026 and issued its decision on Mar 30, 2026, 17 days later.

← All decisions in March 2026

Sources