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Apieron Insight EnO System

by Apieron, Inc.

510(k) K083617

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK083617 Date27 Jan 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MXA
Device Class
Class II
Regulation
21 CFR Part 862.3080
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Apieron Insight EnO System is a device that measures exhaled nitric oxide (eNO) in human breath as an asthma inflammation marker. It comprises a monitor and a multi-use disposable sensor cartridge. The system is used to quantitatively measure exhaled nitric oxide in expired human breath as a marker of inflammation in persons with asthma.

The Apieron Insight EnO System is supplied with a monitor and disposable sensor cartridges. It is a non-invasive method to measure a decrease in eNO in asthma patients that often occurs after treatment. The device has an FDA 510(k) authorization, with a product code of MXA and a regulation number of 862.3080.

Other devices from Apieron, Inc.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Apieron Insight EnO System used for?

    The Apieron Insight EnO System is used to quantitatively measure exhaled nitric oxide in expired human breath as a marker of inflammation in persons with asthma, helping to monitor treatment effectiveness.

  • Is the Apieron Insight EnO System invasive?

    No, the Apieron Insight EnO System is a non-invasive method to measure exhaled nitric oxide, using a monitor and disposable sensor cartridges.

  • What is supplied with the Apieron Insight EnO System?

    The Apieron Insight EnO System is supplied with a monitor and multi-use disposable sensor cartridges.

  • How does the Apieron Insight EnO System help with asthma treatment?

    The Apieron Insight EnO System helps with asthma treatment by measuring a decrease in exhaled nitric oxide in asthma patients that often occurs after treatment, allowing for more effective monitoring and adjustment of treatment plans.