# K182874: Fenom Pro Nitric Oxide Test

- Pathway: 510(k) (Traditional)
- Applicant: Spirosure, Inc.
- Decided: Feb 13, 2019 after 124 days
- Product code: MXA (System, Test, Breath Nitric Oxide)
- Device class: 2
- Regulation: 21 CFR 862.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN030001 (2003). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072816: Niox Mino, Aerocrine AB (2008) Summary page 4.

## Most influential descendants
- K213611: Fenom Pro (2023), 1 descendant of its own
- K251674: Fenom Flo™ FeNO Monitoring System (2025), 0 descendants of its own

## Recalls of this device
- Feb 26, 2021 · Class II · Z-1284-2021: Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readings: 1) Drift in the 

## Indications for use
Fenom Pro™ Nitric Oxide Test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment. Measurement of FeNO by Fenom Pro™ is a 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 therapeutic effect in patients with elevated FeNO levels. FeNO measurements are to be used as an adjunct to established clinical assessments. Fenom Pro™ is suitable for children, approximately 7-17 years, and adults 18 years and older. Testing using the Fenom Pro™ should only be done in a point-of-care healthcare setting under professional supervision. Fenom Pro™ should not be used in critical care, emergency care or in anesthesiology.

Source page: https://510kreport.com/device/K182874
Methodology: https://510kreport.com/methodology