Panels › Clinical Toxicology › Product code MXA · Class 2
System, Test, Breath Nitric Oxide
Regulation 862.3080
1510(k)s in 12 months (15 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MXA
| Company | 510(k)s | Recalls |
|---|---|---|
| Aerocrine AB | 6 | 0 |
| Apieron, Inc. | 2 | 0 |
| Bosch Healthcare Solutions GmbH | 2 | 0 |
| Caire Diagnostics, Inc. | 1 | 1 |
| Bedfont Scientific, Ltd. | 1 | 0 |
| Circassia AB | 1 | 0 |
| Mgc Diagnostics Corporation | 1 | 0 |
| Spirosure, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 26, 2025 | K251674 | Fenom Flo FeNO Monitoring System Mgc Diagnostics Corporation | MXA |
| Sep 11, 2025 | K243926 | Vivatmo pro-S Bosch Healthcare Solutions GmbH, DE | MXA |
| Feb 22, 2024 | K233775 | Vivatmo pro Bosch Healthcare Solutions GmbH, DE | MXA |
| Jun 7, 2023 | K213611 | Fenom Pro Caire Diagnostics, Inc. | MXA |
| Dec 17, 2021 | K203695 | NObreath® Bedfont Scientific, Ltd., GB | MXA |
| Feb 13, 2019 | K182874 | Fenom Pro Nitric Oxide Test Spirosure, Inc. | MXA |
| Nov 22, 2017 | K170983 | NIOX VERO Circassia AB, SE | MXA |
| Feb 26, 2015 | K150233 | NIOX VERO Airway Inflammation Monitor Aerocrine AB, SE | MXA |
| Nov 6, 2014 | K133898 | NIOX VERO AIRWAY INFLAMMATION MONITOR Aerocrine AB | MXA |
| Dec 27, 2012 | K123683 | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR Aerocrine AB, SE | MXA |
| Sep 2, 2010 | K101034 | NIOX MINO MODEL 09-1000 Aerocrine AB, SE | MXA |
| Jan 27, 2009 | K083617 | APIERON INSIGHT ENO SYSTEM Apieron, Inc. | MXA |
| Mar 14, 2008 | K073265 | APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM Apieron, Inc. | MXA |
| Mar 3, 2008 | K072816 | NIOX MINO Aerocrine AB | MXA |
| Apr 30, 2003 | DEN030001 | NIOX ARTICLE NO: 02-1000 Aerocrine AB | MXA |
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