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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 / August 2026 / K261362

510(k) cleared

Xpert Hemorrhagic Fever

Cepheid · Aug 7, 2026 · K261362

FDA cleared the Xpert Hemorrhagic Fever from Cepheid on Aug 7, 2026 under K261362, a dual track 510(k). The device falls under product code QVR, Multiplex Nucleic Acid Detection System For Biothreat Agents, regulated at 21 CFR 866.4000 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Apr 27, 2026. The decision came 102 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cepheid has 2 other decisions in the tracker over the last 12 months: K253653 (Xpert Hemorrhagic Fever), K251721 (Xpert GI Panel).

Questions & Answers

What did FDA clear under K261362?

K261362 is the FDA 510(k) for Xpert Hemorrhagic Fever, submitted by Cepheid. FDA's decision date was Aug 7, 2026, under product code QVR (Multiplex Nucleic Acid Detection System For Biothreat Agents).

Who makes the Xpert Hemorrhagic Fever?

Cepheid, based in Sunnyvale, CA, is the applicant of record for K261362.

How long did the K261362 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Aug 7, 2026, 102 days later.

← All decisions in August 2026

Sources