Cleared Traditional

K170983 - NIOX VERO

K170983 is an FDA 510(k) clearance for NIOX VERO, manufactured by Circassia AB. The device is a Class 2 Chemistry device with product code MXA cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K170983 · Circassia AB · Chemistry device
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Nov 2017
Decision
233d
Days
Class 2
Risk

K170983 is an FDA 510(k) clearance for the NIOX VERO. Classified as System, Test, Breath Nitric Oxide (product code MXA), Class II - Special Controls.

Submitted by Circassia AB (Uppsala, SE). The FDA issued a Cleared decision on November 22, 2017 after a review of 233 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 Circassia AB devices

FDA 510(k) Submission Details - K170983

510(k) Number K170983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2017
Decision Date November 22, 2017
Days to Decision 233 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
145d slower than avg
Panel avg: 88d · This submission: 233d
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 K170983.
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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