# K251674: Fenom Flo™ FeNO Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Mgc Diagnostics Corporation
- Decided: Nov 26, 2025 after 180 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: 4 generations back to DEN030001 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213611: Fenom Pro, Caire Diagnostics, Inc. (2023) Summary page 5.

## Indications for use
Fenom Flo™ FeNO Monitoring System 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 decreases in response to anti-inflammatory treatment. Fenom Flo measures fractional exhaled nitric oxide (FeNO) according to guidelines established by the American Thoracic Society. Measurement of FeNO by Fenom Flo is a non-invasive quantitative 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 Flo is suitable for adults and children ages seven years and older. Fenom Flo should be used in a point-of-care healthcare setting under professional supervision. Fenom Flo should not be used in critical care, emergency care, or anesthesiology.

Source page: https://510kreport.com/device/K251674
Methodology: https://510kreport.com/methodology