Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3080](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3080) → MXA — System, Test, Breath Nitric Oxide # MXA · System, Test, Breath Nitric Oxide _Clinical Toxicology · 21 CFR 862.3080 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA ## Overview - **Product Code:** MXA - **Device Name:** System, Test, Breath Nitric Oxide - **Regulation:** [21 CFR 862.3080](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3080) - **Device Class:** 2 - **Review Panel:** [Clinical Toxicology](/submissions/TX) ## 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](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K251674.md) | Fenom Flo™ FeNO Monitoring System | Mgc Diagnostics Corporation | Nov 26, 2025 | SESE | | [K243926](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K243926.md) | Vivatmo pro-S | Bosch Healthcare Solutions GmbH | Sep 11, 2025 | SESE | | [K233775](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K233775.md) | Vivatmo pro | Bosch Healthcare Solutions GmbH | Feb 22, 2024 | SESE | | [K213611](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K213611.md) | Fenom Pro | Caire Diagnostics, Inc. | Jun 7, 2023 | SESE | | [K203695](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K203695.md) | NObreath® | Bedfont Scientific, Ltd. | Dec 17, 2021 | SESE | | [K182874](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K182874.md) | Fenom Pro Nitric Oxide Test | Spirosure, Inc. | Feb 13, 2019 | SESE | | [K170983](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K170983.md) | NIOX VERO | Circassia AB | Nov 22, 2017 | SESE | | [K150233](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K150233.md) | NIOX VERO Airway Inflammation Monitor | Aerocrine AB | Feb 26, 2015 | SESE | | [K133898](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K133898.md) | NIOX VERO AIRWAY INFLAMMATION MONITOR | Aerocrine AB | Nov 6, 2014 | SESE | | [K123683](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K123683.md) | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR | Aerocrine AB | Dec 27, 2012 | SESE | | [K101034](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K101034.md) | NIOX MINO MODEL 09-1000 | Aerocrine AB | Sep 2, 2010 | SESE | | [K083617](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K083617.md) | APIERON INSIGHT ENO SYSTEM | Apieron, Inc. | Jan 27, 2009 | SESE | | [K073265](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K073265.md) | APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM | Apieron, Inc. | Mar 14, 2008 | SESE | | [K072816](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K072816.md) | NIOX MINO | Aerocrine AB | Mar 3, 2008 | SESE | | [DEN030001](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/DEN030001.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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