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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 / September 2025 / K252102

510(k) cleared

Alinity m HCV

Abbott Molecular, Inc. · Sep 25, 2025 · K252102

FDA cleared the Alinity m HCV from Abbott Molecular, Inc. on Sep 25, 2025 under K252102, a traditional 510(k). The device falls under product code MZP, Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus, regulated at 21 CFR 866.3170 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jul 3, 2025. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252102?

K252102 is the FDA 510(k) for Alinity m HCV, submitted by Abbott Molecular, Inc.. FDA's decision date was Sep 25, 2025, under product code MZP (Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus).

Who makes the Alinity m HCV?

Abbott Molecular, Inc., based in Des Plaines, IL, is the applicant of record for K252102.

How long did the K252102 review take?

FDA received the submission on Jul 3, 2025 and issued its decision on Sep 25, 2025, 84 days later.

← All decisions in September 2025