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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 / K263120

510(k) cleared

Xpert Xpress CoV-2/Flu plus

Cepheid® · Oct 2, 2026 · K263120

FDA cleared the Xpert Xpress CoV-2/Flu plus from Cepheid® on Oct 2, 2026 under K263120, a special 510(k). The device falls under product code QOF, Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, regulated at 21 CFR 866.3981 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Sep 4, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Cepheid® has one other decision in the tracker over the last 12 months: K261867 (Xpert Carba-R).

Questions & Answers

What did FDA clear under K263120?

K263120 is the FDA 510(k) for Xpert Xpress CoV-2/Flu plus, submitted by Cepheid®. FDA's decision date was Oct 2, 2026, under product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents).

Who makes the Xpert Xpress CoV-2/Flu plus?

Cepheid®, based in Sunnyvale, CA, is the applicant of record for K263120.

How long did the K263120 review take?

FDA received the submission on Sep 4, 2026 and issued its decision on Oct 2, 2026, 28 days later.

← All decisions in October 2026

Sources