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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 / July 2026 / K261475

510(k) cleared

BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit

Biofire Defense, LLC · Jul 17, 2026 · K261475

FDA cleared the BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit from Biofire Defense, LLC on Jul 17, 2026 under K261475, a traditional 510(k). The device falls under product code PMN, Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, regulated at 21 CFR 866.3920 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on May 5, 2026. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Biofire Defense, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261475?

K261475 is the FDA 510(k) for BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit, submitted by Biofire Defense, LLC. FDA's decision date was Jul 17, 2026, under product code PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays).

Who makes the BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit?

Biofire Defense, LLC, based in Salt Lake City, UT, is the applicant of record for K261475.

How long did the K261475 review take?

FDA received the submission on May 5, 2026 and issued its decision on Jul 17, 2026, 73 days later.

← All decisions in July 2026