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510(k) K251674

Fenom Flo™ FeNO Monitoring System by Mgc Diagnostics Corporation — Product Code MXA

K251674 is an FDA 510(k) premarket notification submitted by Mgc Diagnostics Corporation for the device "Fenom Flo™ FeNO Monitoring System". The FDA issued a decision of Substantially Equivalent on November 26, 2025. The device falls under product code MXA (System, Test, Breath Nitric Oxide), a Class II device regulated under 21 CFR 862.3080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2025
Date Received
May 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Breath Nitric Oxide
Device Class
Class II
Regulation Number
862.3080
Review Panel
CH
Submission Type

Other clearances for product code MXA

  • K243926 — Vivatmo pro-S (September 11, 2025)
  • K233775 — Vivatmo pro (February 22, 2024)
  • K213611 — Fenom Pro (June 7, 2023)
  • K203695 — NObreath® (December 17, 2021)
  • K182874 — Fenom Pro Nitric Oxide Test (February 13, 2019)
  • K170983 — NIOX VERO (November 22, 2017)
  • K150233 — NIOX VERO Airway Inflammation Monitor (February 26, 2015)
  • K133898 — NIOX VERO AIRWAY INFLAMMATION MONITOR (November 6, 2014)
  • K123683 — NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR (December 27, 2012)
  • K101034 — NIOX MINO MODEL 09-1000 (September 2, 2010)

FDA data resources