# K170983: Niox Vero

- Pathway: 510(k) (Traditional)
- Applicant: Circassia AB
- Decided: Nov 22, 2017 after 233 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
Longest line of descent: 5 generations back to DEN030001 (2003). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150233: NIOX VERO Airway Inflammation Monitor, Aerocrine AB (2015) Summary page 4.

## Most influential descendants
- K203695: NObreath® (2021), 0 descendants of its own

## Indications for use
NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some airway inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society. Measurement of FeNO by NIOX VERO is a quantitative, non-invasive, simple and safe method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels. NIOX VERO is suitable for children, 7- 17 years, and adults 18 years and older. NIOX VERO 10 second test mode is for age 7 and up NIOX VERO 6 second test mode is for ages 7-10 only who cannot successfully complete a 10 second test. FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The NIOX VERO is intended for prescription use and should only be used as directed in the NIOX VERO User Manual by trained healthcare professionals. NIOX VERO cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation. NIOX VERO should not be used in critical care, emergency care or in anesthesiology.

Source page: https://510kreport.com/device/K170983
Methodology: https://510kreport.com/methodology