FDA Product Code MXA: System, Test, Breath Nitric Oxide
Leading manufacturers include Bosch Healthcare Solutions GmbH, Bedfont Scientific, Ltd. and Caire Diagnostics, Inc..
FDA 510(k) Cleared System, Test, Breath Nitric Oxide Devices (Product Code MXA)
About Product Code MXA - Regulatory Context
510(k) Submission Activity
15 total 510(k) submissions under product code MXA since 2003, with 14 receiving FDA clearance (average review time: 180 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under MXA have taken an average of 223 days to reach a decision - up from 173 days historically. Manufacturers should account for longer review timelines in current project planning.
MXA devices are reviewed by the Chemistry panel. Browse all Chemistry devices →