Cleared Traditional

K072816 - NIOX MINO (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072816 · Aerocrine AB · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
153d
Days
Class 2
Risk

K072816 is an FDA 510(k) clearance for the NIOX MINO. Classified as System, Test, Breath Nitric Oxide (product code MXA), Class II - Special Controls.

Submitted by Aerocrine AB (Washington, US). The FDA issued a Cleared decision on March 3, 2008 after a review of 153 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3080 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Aerocrine AB devices

Submission Details

510(k) Number K072816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2007
Decision Date March 03, 2008
Days to Decision 153 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 88d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.