Cleared Special

K101034 - NIOX MINO MODEL 09-1000

K101034 is an FDA 510(k) clearance for NIOX MINO MODEL 09-1000, 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 141-day FDA review.

K101034 · Aerocrine AB · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
141d
Days
Class 2
Risk

K101034 is an FDA 510(k) clearance for the NIOX MINO MODEL 09-1000. 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 September 2, 2010 after a review of 141 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K101034

510(k) Number K101034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2010
Decision Date September 02, 2010
Days to Decision 141 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
52d slower than avg
Panel avg: 89d · This submission: 141d
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 K101034.
NIOX VERO Airway Inflammation Monitor
K150233 · Aerocrine AB · Feb 2015
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
APIERON INSIGHT ENO SYSTEM
K083617 · Apieron, Inc. · Jan 2009
APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
K073265 · Apieron, Inc. · Mar 2008
NIOX MINO
K072816 · Aerocrine AB · Mar 2008
K101034 · NIOX MINO MODEL 09-1000
Download PDF FDA Summary Aerocrine AB