# DEN030001: Niox Article NO: 02-1000

- Pathway: De Novo (Post-NSE)
- Applicant: Aerocrine AB
- Decided: Apr 30, 2003 after 43 days
- Product code: MXA (System, Test, Breath Nitric Oxide)
- Device class: 2
- Regulation: 21 CFR 862.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K072816: Niox Mino (2008), 9 descendants of its own
- K101034: Niox Mino Model 09-1000 (2010), 5 descendants of its own
- K133898: Niox Vero Airway Inflammation Monitor (2014), 3 descendants of its own
- K182874: Fenom Pro Nitric Oxide Test (2019), 2 descendants of its own
- K150233: NIOX VERO Airway Inflammation Monitor (2015), 2 descendants of its own

Source page: https://510kreport.com/device/DEN030001
Methodology: https://510kreport.com/methodology