# K083617: Apieron Insight Eno System

- Pathway: 510(k) (Special)
- Applicant: Apieron, Inc.
- Decided: Jan 27, 2009 after 50 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: 1 generation back to K073265 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073265: Apieron Insight Exhaled Nitric Oxide (Eno) System, Apieron, Inc. (2008) Summary page 1.

## Indications for use
The intended use of the Apieron INSIGHT eNO System is to quantitatively measure exhaled nitric oxide (eNO) in expired human breath as a marker of inflammation in persons with asthma. Measurement of eNO in expired human breath by the Apieron INSIGHT eNO System is a non-invasive, simple and safe method to measure a decrease in eNO in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of the therapeutic effects in patients with elevated eNO levels. The Apieron INSIGHT eNO System is suitable for use in children ages 8 to 17 years of age, and in adults 18 years of age and older. eNO measurements, as an adjunct to established clinical assessments, provide the physician an objective marker to evaluate the patient's response to anti-inflammatory therapy. The Apieron INSIGHT eNO System can be used by trained operators in a physician's-office laboratory setting. The Apieron INSIGHT eNO System should not be used in critical care, emergency care or in anesthesiology.

Source page: https://510kreport.com/device/K083617
Methodology: https://510kreport.com/methodology