Not Cleared Post-NSE

DEN030001 - NIOX ARTICLE NO: 02-1000 (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN030001 · Aerocrine AB · Toxicology device
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Apr 2003
Decision
43d
Days
Class 2
Risk

DEN030001 is an FDA 510(k) submission (not cleared) for the NIOX ARTICLE NO: 02-1000. Classified as System, Test, Breath Nitric Oxide (product code MXA), Class II - Special Controls.

Submitted by Aerocrine AB (San Diego, US). The FDA issued a Not Cleared (DENG) decision on April 30, 2003 after a review of 43 days.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3080 - the FDA toxicology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Toxicology review framework.

View all Aerocrine AB devices

Submission Details

510(k) Number DEN030001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 18, 2003
Decision Date April 30, 2003
Days to Decision 43 days
Submission Type Post-NSE
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 87d · This submission: 43d
Pathway characteristics

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 Toxicology devices follow this clearance model.