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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 / K251868

510(k) cleared

Panther Fusion GI Bacterial Assay

Hologic · Sep 25, 2025 · K251868

FDA cleared the Panther Fusion GI Bacterial Assay from Hologic on Sep 25, 2025 under K251868, 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 18, 2025. The decision came 99 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hologic has 3 other decisions in the tracker over the last 12 months: K262792 (Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)), K253634 (CoolSeal Generator® (CSL-200-90)), K251993 (Panther Fusion GI Expanded Bacterial Assay).

Questions & Answers

What did FDA clear under K251868?

K251868 is the FDA 510(k) for Panther Fusion GI Bacterial Assay, submitted by Hologic. FDA's decision date was Sep 25, 2025, under product code PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System).

Who makes the Panther Fusion GI Bacterial Assay?

Hologic, based in San Diego, CA, is the applicant of record for K251868.

How long did the K251868 review take?

FDA received the submission on Jun 18, 2025 and issued its decision on Sep 25, 2025, 99 days later.

← All decisions in September 2025

Sources