# MXA: System, Test, Breath Nitric Oxide

- Device class: 2; regulation: 21 CFR 862.3080; FDA's rule: 510(k) required
- FDA decisions: 15
- 510(k) review time 2021–2025: median 265 days (middle half 180–364)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 1
- 2012: 1
- 2014: 1
- 2015: 1
- 2017: 1
- 2019: 1
- 2021: 1
- 2023: 1
- 2024: 1
- 2025: 2

## Most-cited predicates
- K101034: Niox Mino Model 09-1000 (2010), cited by 2
- K072816: Niox Mino (2008), cited by 2
- K182874: Fenom Pro Nitric Oxide Test (2019), cited by 1
- K213611: Fenom Pro (2023), cited by 1
- K233775: Vivatmo pro (2024), cited by 1
- K150233: NIOX VERO Airway Inflammation Monitor (2015), cited by 1
- K133898: Niox Vero Airway Inflammation Monitor (2014), cited by 1
- K073265: Apieron Insight Exhaled Nitric Oxide (Eno) System (2008), cited by 1
- DEN030001: Niox Article NO: 02-1000 (2003), cited by 1
- K170983: Niox Vero (2017), cited by 1

Source page: https://510kreport.com/product-code/MXA
Data by year (CSV): https://510kreport.com/product-code/MXA.csv