MXA
15 FDA 510(k) clearances · Product code
141 daysmedian time to decision
364 days90th percentile
15clearances measured
FDA profile
- Official device name
- System, Test, Breath Nitric Oxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3080
- Medical specialty
- Clinical Toxicology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Fenom Flo™ FeNO Monitoring System (K251674) | Mgc Diagnostics Corporation | 2025-11-26 |
| Vivatmo pro-S (K243926) | Bosch Healthcare Solutions GmbH | 2025-09-11 |
| Vivatmo pro (K233775) | Bosch Healthcare Solutions GmbH | 2024-02-22 |
| Fenom Pro (K213611) | Caire Diagnostics, Inc. | 2023-06-07 |
| NObreath® (K203695) | Bedfont Scientific, Ltd. | 2021-12-17 |
| Fenom Pro Nitric Oxide Test (K182874) | Spirosure, Inc. | 2019-02-13 |
| NIOX VERO (K170983) | Circassia AB | 2017-11-22 |
| NIOX VERO Airway Inflammation Monitor (K150233) | Aerocrine AB | 2015-02-26 |
| NIOX VERO AIRWAY INFLAMMATION MONITOR (K133898) | Aerocrine AB | 2014-11-06 |
| NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR (K123683) | Aerocrine AB | 2012-12-27 |
| NIOX MINO MODEL 09-1000 (K101034) | Aerocrine AB | 2010-09-02 |
| APIERON INSIGHT ENO SYSTEM (K083617) | Apieron, Inc. | 2009-01-27 |
| APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM (K073265) | Apieron, Inc. | 2008-03-14 |
| NIOX MINO (K072816) | Aerocrine AB | 2008-03-03 |
| NIOX ARTICLE NO: 02-1000 (DEN030001) | Aerocrine AB | 2003-04-30 |
Track MXA automatically
Every clearance here is in the API, with alerts when new ones post.