Cleared Special

APIERON INSIGHT ENO SYSTEM (K083617) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K083617 · Apieron, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
50d
Days
Class 2
Risk

K083617 is an FDA 510(k) clearance for the APIERON INSIGHT ENO SYSTEM. Classified as System, Test, Breath Nitric Oxide (product code MXA), Class II - Special Controls.

Submitted by Apieron, Inc. (Menlo Park, US). The FDA issued a Cleared decision on January 27, 2009 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3080 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Apieron, Inc. devices

Submission Details

510(k) Number K083617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2008
Decision Date January 27, 2009
Days to Decision 50 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MXA System, Test, Breath Nitric Oxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3080
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - MXA System, Test, Breath Nitric Oxide

All 14
Devices cleared under the same product code (MXA) and FDA review panel - the closest regulatory comparables to K083617.
Fenom Flo™ FeNO Monitoring System
K251674 · Mgc Diagnostics Corporation · Nov 2025
Vivatmo pro-S
K243926 · Bosch Healthcare Solutions GmbH · Sep 2025
Vivatmo pro
K233775 · Bosch Healthcare Solutions GmbH · Feb 2024
Fenom Pro
K213611 · Caire Diagnostics, Inc. · Jun 2023
NObreath®
K203695 · Bedfont Scientific, Ltd. · Dec 2021
Fenom Pro Nitric Oxide Test
K182874 · Spirosure, Inc. · Feb 2019