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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 / July 2026 / K261867

510(k) cleared

Xpert Carba-R

Cepheid® · Jul 2, 2026 · K261867

FDA cleared the Xpert Carba-R from Cepheid® on Jul 2, 2026 under K261867, a special 510(k). The device falls under product code POC, System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen, regulated at 21 CFR 866.1640 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 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: K263120 (Xpert Xpress CoV-2/Flu plus).

Questions & Answers

What did FDA clear under K261867?

K261867 is the FDA 510(k) for Xpert Carba-R, submitted by Cepheid®. FDA's decision date was Jul 2, 2026, under product code POC (System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen).

Who makes the Xpert Carba-R?

Cepheid®, based in Sunnyvale, CA, is the applicant of record for K261867.

How long did the K261867 review take?

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

← All decisions in July 2026

Sources