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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 / November 2025 / K251674

510(k) cleared

Fenom Flo FeNO Monitoring System

Mgc Diagnostics Corporation · Nov 26, 2025 · K251674

FDA cleared the Fenom Flo FeNO Monitoring System from Mgc Diagnostics Corporation on Nov 26, 2025 under K251674, a traditional 510(k). The device falls under product code MXA, System, Test, Breath Nitric Oxide, regulated at 21 CFR 862.3080 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on May 30, 2025. The decision came 180 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Mgc Diagnostics Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251674?

K251674 is the FDA 510(k) for Fenom Flo FeNO Monitoring System, submitted by Mgc Diagnostics Corporation. FDA's decision date was Nov 26, 2025, under product code MXA (System, Test, Breath Nitric Oxide).

Who makes the Fenom Flo FeNO Monitoring System?

Mgc Diagnostics Corporation, based in St. Paul, MN, is the applicant of record for K251674.

How long did the K251674 review take?

FDA received the submission on May 30, 2025 and issued its decision on Nov 26, 2025, 180 days later.

← All decisions in November 2025