Product code MXA— Clinical Toxicology
APIERON INSIGHT ENO SYSTEM
- Classification name
- System, Test, Breath Nitric Oxide
- Device class
- Class 2
- Regulation
- 21 CFR 862.3080
- Advisory panel
- Clinical Toxicology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code MXA
FDA has cleared devices under product code MXA between 2003 and 2025, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2024
- 2023
- 2021
- 2019
- 2017
- 2015
- 2014
- 2012
- 2010
- 2009
- 2008
- 2003
Top applicants under product code MXA
Recent clearances under product code MXA
- K251674 — Fenom Flo FeNO Monitoring System
- K243926 — Vivatmo pro-S
- K233775 — Vivatmo pro
- K213611 — Fenom Pro
- K203695 — NObreath®
- K182874 — Fenom Pro Nitric Oxide Test
- K170983 — NIOX VERO
- K150233 — NIOX VERO Airway Inflammation Monitor
- K133898 — NIOX VERO AIRWAY INFLAMMATION MONITOR
- K123683 — NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
- K101034 — NIOX MINO MODEL 09-1000
- K083617 — APIERON INSIGHT ENO SYSTEM
- K073265 — APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
- K072816 — NIOX MINO
- DEN030001 — NIOX ARTICLE NO: 02-1000
Data sourced from openFDA. This site is unofficial and independent of the FDA.