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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 / January 2026 / K251721

510(k) cleared

Xpert GI Panel

Cepheid · Jan 16, 2026 · K251721

FDA cleared the Xpert GI Panel from Cepheid on Jan 16, 2026 under K251721, a traditional 510(k). The device falls under product code PCH, Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, regulated at 21 CFR 866.3990 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 4, 2025. The decision came 226 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), K253653 (Xpert Hemorrhagic Fever).

Questions & Answers

What did FDA clear under K251721?

K251721 is the FDA 510(k) for Xpert GI Panel, submitted by Cepheid. FDA's decision date was Jan 16, 2026, under product code PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System).

Who makes the Xpert GI Panel?

Cepheid, based in Sunnyvale, CA, is the applicant of record for K251721.

How long did the K251721 review take?

FDA received the submission on Jun 4, 2025 and issued its decision on Jan 16, 2026, 226 days later.

← All decisions in January 2026

Sources