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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 / December 2025 / K250925

510(k) cleared

ADVIA Centaur Cytokeratin Fragment 21-1

Fujirebio Diagnostics,Inc. · Dec 16, 2025 · K250925

FDA cleared the ADVIA Centaur Cytokeratin Fragment 21-1 from Fujirebio Diagnostics,Inc. on Dec 16, 2025 under K250925, a traditional 510(k). The device falls under product code OVK, Cytokeratin Fragments 21-1 Eia Kit, regulated at 21 CFR 866.6010 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Mar 27, 2025. The decision came 264 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Fujirebio Diagnostics,Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250925?

K250925 is the FDA 510(k) for ADVIA Centaur Cytokeratin Fragment 21-1, submitted by Fujirebio Diagnostics,Inc.. FDA's decision date was Dec 16, 2025, under product code OVK (Cytokeratin Fragments 21-1 Eia Kit).

Who makes the ADVIA Centaur Cytokeratin Fragment 21-1?

Fujirebio Diagnostics,Inc., based in Malvern, PA, is the applicant of record for K250925.

How long did the K250925 review take?

FDA received the submission on Mar 27, 2025 and issued its decision on Dec 16, 2025, 264 days later.

← All decisions in December 2025