Cleared Traditional

K133898 - NIOX VERO AIRWAY INFLAMMATION MONITOR

K133898 is an FDA 510(k) clearance for NIOX VERO AIRWAY INFLAMMATION MONITOR, manufactured by Aerocrine AB. The device is a Class 2 Chemistry device with product code MXA cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K133898 · Aerocrine AB · Chemistry device
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Nov 2014
Decision
321d
Days
Class 2
Risk

K133898 is an FDA 510(k) clearance for the NIOX VERO AIRWAY INFLAMMATION MONITOR. Classified as System, Test, Breath Nitric Oxide (product code MXA), Class II - Special Controls.

Submitted by Aerocrine AB (Morrisville, US). The FDA issued a Cleared decision on November 6, 2014 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K133898

510(k) Number K133898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2013
Decision Date November 06, 2014
Days to Decision 321 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 88d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - MXA System, Test, Breath Nitric Oxide

All 11
Devices cleared under the same product code (MXA) and FDA review panel - the closest regulatory comparables to K133898.
Fenom Pro Nitric Oxide Test
K182874 · Spirosure, Inc. · Feb 2019
NIOX VERO
K170983 · Circassia AB · Nov 2017
NIOX VERO Airway Inflammation Monitor
K150233 · Aerocrine AB · Feb 2015
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
K123683 · Aerocrine AB · Dec 2012
NIOX MINO
K072816 · Aerocrine AB · Mar 2008
NIOX ARTICLE NO: 02-1000
DEN030001 · Aerocrine AB · Apr 2003