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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 / K252072

510(k) cleared

Francisella tularensis Real-time PCR assay

Centers for Disease Control and Prevention · Sep 30, 2025 · K252072

FDA cleared the Francisella tularensis Real-time PCR assay from Centers for Disease Control and Prevention on Sep 30, 2025 under K252072, a traditional 510(k). The device falls under product code SGA, Biothreat Microbial Agent Nucleic Acid Detection Test, regulated at 21 CFR 866.4000 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Jul 1, 2025. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Centers for Disease Control and Prevention has one other decision in the tracker over the last 12 months: K260812 (Francisella tularensis Real-time PCR Assay).

Questions & Answers

What did FDA clear under K252072?

K252072 is the FDA 510(k) for Francisella tularensis Real-time PCR assay, submitted by Centers for Disease Control and Prevention. FDA's decision date was Sep 30, 2025, under product code SGA (Biothreat Microbial Agent Nucleic Acid Detection Test).

Who makes the Francisella tularensis Real-time PCR assay?

Centers for Disease Control and Prevention, based in Atlanta, GA, is the applicant of record for K252072.

How long did the K252072 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Sep 30, 2025, 91 days later.

← All decisions in September 2025

Sources