Cleared Traditional

K170983 - NIOX VERO (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 Chemistry devices follow this clearance model.

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All 14
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