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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 / May 2026 / K260577

510(k) cleared

FilmArray TF Control Panel M527

Maine Molecular Quality Controls, Inc. · May 19, 2026 · K260577

FDA cleared the FilmArray TF Control Panel M527 from Maine Molecular Quality Controls, Inc. on May 19, 2026 under K260577, 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 Feb 20, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K260577?

K260577 is the FDA 510(k) for FilmArray TF Control Panel M527, submitted by Maine Molecular Quality Controls, Inc.. FDA's decision date was May 19, 2026, under product code PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays).

Who makes the FilmArray TF Control Panel M527?

Maine Molecular Quality Controls, Inc., based in Saco, ME, is the applicant of record for K260577.

How long did the K260577 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on May 19, 2026, 88 days later.

← All decisions in May 2026