WHERE ARE YOU?

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

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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).

This is the only decision on file for Cepheid® in the last 12 months of the tracker.

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