MXA · System, Test, Breath Nitric Oxide
Clinical Toxicology · 21 CFR 862.3080 · Class 2
Overview
| Product Code | MXA |
|---|---|
| Device Name | System, Test, Breath Nitric Oxide |
| Regulation | 21 CFR 862.3080 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
Identification
A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.
Classification Rationale
Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breath Nitric Oxide Test System.” See § 862.1(d) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breath Nitric Oxide Test System.” See § 862.1(d) for the availability of this guidance document.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251674 | Fenom Flo FeNO Monitoring System | Mgc Diagnostics Corporation | Nov 26, 2025 | SESE |
| K243926 | Vivatmo pro-S | Bosch Healthcare Solutions GmbH | Sep 11, 2025 | SESE |
| K233775 | Vivatmo pro | Bosch Healthcare Solutions GmbH | Feb 22, 2024 | SESE |
| K213611 | Fenom Pro | Caire Diagnostics, Inc. | Jun 7, 2023 | SESE |
| K203695 | NObreath® | Bedfont Scientific, Ltd. | Dec 17, 2021 | SESE |
| K182874 | Fenom Pro Nitric Oxide Test | Spirosure, Inc. | Feb 13, 2019 | SESE |
| K170983 | NIOX VERO | Circassia AB | Nov 22, 2017 | SESE |
| K150233 | NIOX VERO Airway Inflammation Monitor | Aerocrine AB | Feb 26, 2015 | SESE |
| K133898 | NIOX VERO AIRWAY INFLAMMATION MONITOR | Aerocrine AB | Nov 6, 2014 | SESE |
| K123683 | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR | Aerocrine AB | Dec 27, 2012 | SESE |
| K101034 | NIOX MINO MODEL 09-1000 | Aerocrine AB | Sep 2, 2010 | SESE |
| K083617 | APIERON INSIGHT ENO SYSTEM | Apieron, Inc. | Jan 27, 2009 | SESE |
| K073265 | APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM | Apieron, Inc. | Mar 14, 2008 | SESE |
| K072816 | NIOX MINO | Aerocrine AB | Mar 3, 2008 | SESE |
| DEN030001 | NIOX ARTICLE NO: 02-1000 | Aerocrine AB | Apr 30, 2003 | DENG |
Top Applicants
- Aerocrine AB — 6 clearances
- Apieron, Inc. — 2 clearances
- Bosch Healthcare Solutions GmbH — 2 clearances
- Bedfont Scientific, Ltd. — 1 clearance
- Caire Diagnostics, Inc. — 1 clearance
