Cleared Traditional

Fenom Flo? FeNO Monitoring System

K251674 · Mgc Diagnostics Corporation · Chemistry
Nov 2025
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K251674 is an FDA 510(k) clearance for the Fenom Flo? FeNO Monitoring System, a System, Test, Breath Nitric Oxide (Class II — Special Controls, product code MXA), submitted by Mgc Diagnostics Corporation (St. Paul, US). The FDA issued a Cleared decision on November 26, 2025, 180 days after receiving the submission on May 30, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3080.

Submission Details

510(k) Number K251674 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2025
Decision Date November 26, 2025
Days to Decision 180 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MXA — System, Test, Breath Nitric Oxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3080