Cleared Special

K083617 - APIERON INSIGHT ENO SYSTEM

K083617 is an FDA 510(k) clearance for APIERON INSIGHT ENO SYSTEM, manufactured by Apieron, Inc.. The device is a Class 2 Chemistry device with product code MXA cleared through the Special 510(k) pathway after a 50-day FDA review.

K083617 · Apieron, Inc. · Chemistry device
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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

FDA 510(k) Submission Details - K083617

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.

MXA Device Classification - Class 2, Special Controls

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.