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MXA — System, Test, Breath Nitric Oxide Class II

FDA Device Classification

Classification Details

Product Code
MXA
Device Class
Class II
Regulation Number
862.3080
Submission Type
Review Panel
CH
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251674mgc diagnostics corporationFenom Flo™ FeNO Monitoring SystemNovember 26, 2025
K243926bosch healthcare solutionsVivatmo pro-SSeptember 11, 2025
K233775bosch healthcare solutionsVivatmo proFebruary 22, 2024
K213611caire diagnosticsFenom ProJune 7, 2023
K203695bedfont scientificNObreath®December 17, 2021
K182874spirosureFenom Pro Nitric Oxide TestFebruary 13, 2019
K170983circassiaNIOX VERONovember 22, 2017
K150233aerocrineNIOX VERO Airway Inflammation MonitorFebruary 26, 2015
K133898aerocrineNIOX VERO AIRWAY INFLAMMATION MONITORNovember 6, 2014
K123683aerocrineNIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITORDecember 27, 2012
K101034aerocrineNIOX MINO MODEL 09-1000September 2, 2010
K083617apieronAPIERON INSIGHT ENO SYSTEMJanuary 27, 2009
K073265apieronAPIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEMMarch 14, 2008
K072816aerocrineNIOX MINOMarch 3, 2008
DEN030001aerocrineNIOX ARTICLE NO: 02-1000April 30, 2003