MXA — System, Test, Breath Nitric Oxide Class II
FDA product code MXA covers "System, Test, Breath Nitric Oxide", a Class II medical device regulated under 21 CFR 862.3080. Submissions are reviewed by the Clinical Toxicology panel. At least 15 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251674 | Mgc Diagnostics Corporation | Fenom Flo FeNO Monitoring System | Nov 26, 2025 |
| K243926 | Bosch Healthcare Solutions | Vivatmo pro-S | Sep 11, 2025 |
| K233775 | Bosch Healthcare Solutions | Vivatmo pro | Feb 22, 2024 |
| K213611 | Caire Diagnostics | Fenom Pro | Jun 7, 2023 |
| K203695 | Bedfont Scientific | NObreath® | Dec 17, 2021 |
| K182874 | Spirosure | Fenom Pro Nitric Oxide Test | Feb 13, 2019 |
| K170983 | Circassia | NIOX VERO | Nov 22, 2017 |
| K150233 | Aerocrine | NIOX VERO Airway Inflammation Monitor | Feb 26, 2015 |
| K133898 | Aerocrine | NIOX VERO AIRWAY INFLAMMATION MONITOR | Nov 6, 2014 |
| K123683 | Aerocrine | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR | Dec 27, 2012 |
| K101034 | Aerocrine | NIOX MINO MODEL 09-1000 | Sep 2, 2010 |
| K083617 | Apieron | APIERON INSIGHT ENO SYSTEM | Jan 27, 2009 |
| K073265 | Apieron | APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM | Mar 14, 2008 |
| K072816 | Aerocrine | NIOX MINO | Mar 3, 2008 |
| DEN030001 | Aerocrine | NIOX ARTICLE NO: 02-1000 | Apr 30, 2003 |