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 / February 2026 / K253653

510(k) cleared

Xpert Hemorrhagic Fever

Cepheid · Feb 20, 2026 · K253653

FDA cleared the Xpert Hemorrhagic Fever from Cepheid on Feb 20, 2026 under K253653, a traditional 510(k). The review panel was Unknown.

FDA logged the submission as received on Nov 20, 2025. The decision came 92 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: K261362 (Xpert Hemorrhagic Fever), K251721 (Xpert GI Panel).

Questions & Answers

What did FDA clear under K253653?

K253653 is the FDA 510(k) for Xpert Hemorrhagic Fever, submitted by Cepheid. FDA's decision date was Feb 20, 2026.

Who makes the Xpert Hemorrhagic Fever?

Cepheid, based in Sunnyvale, CA, is the applicant of record for K253653.

How long did the K253653 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Feb 20, 2026, 92 days later.

← All decisions in February 2026