# K213611: Fenom Pro

- Pathway: 510(k) (Traditional)
- Applicant: Caire Diagnostics, Inc.
- Decided: Jun 7, 2023 after 569 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: 3 generations back to DEN030001 (2003). 3 ancestors in all.
1 later device descends 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)
- K182874: Fenom Pro Nitric Oxide Test, Spirosure, Inc. (2019) Summary page 4.

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

## Indications for use
Fenom Pro 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 Pro measures fractional exhaled nitric oxide according to guidelines established by the American Thoracic Society. Measurement of FENO by Fenom Pro 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 Pro is suitable for adults and children 6 years and older. Fenom Pro should be used 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/K213611
Methodology: https://510kreport.com/methodology