Cleared Special

K150233 - NIOX VERO Airway Inflammation Monitor

K150233 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 Special 510(k) pathway after a 24-day FDA review.

K150233 · Aerocrine AB · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
24d
Days
Class 2
Risk

K150233 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 (Solna, SE). The FDA issued a Cleared decision on February 26, 2015 after a review of 24 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.

FDA 510(k) Submission Details - K150233

510(k) Number K150233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2015
Decision Date February 26, 2015
Days to Decision 24 days
Submission Type Special
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
65d faster than avg
Panel avg: 89d · This submission: 24d
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.

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 K150233.
NObreath®
K203695 · Bedfont Scientific, Ltd. · Dec 2021
Fenom Pro Nitric Oxide Test
K182874 · Spirosure, Inc. · Feb 2019
NIOX VERO
K170983 · Circassia AB · Nov 2017
NIOX VERO AIRWAY INFLAMMATION MONITOR
K133898 · Aerocrine AB · Nov 2014
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
K123683 · Aerocrine AB · Dec 2012
NIOX MINO MODEL 09-1000
K101034 · Aerocrine AB · Sep 2010
K150233 · NIOX VERO Airway Inflammation Monitor
Download PDF FDA Summary Aerocrine AB