Cleared Traditional

K182874 - Fenom Pro Nitric Oxide Test

K182874 is an FDA 510(k) clearance for Fenom Pro Nitric Oxide Test, manufactured by Spirosure, Inc.. The device is a Class 2 Chemistry device with product code MXA cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K182874 · Spirosure, Inc. · Chemistry device
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Feb 2019
Decision
124d
Days
Class 2
Risk

K182874 is an FDA 510(k) clearance for the Fenom Pro Nitric Oxide Test. Classified as System, Test, Breath Nitric Oxide (product code MXA), Class II - Special Controls.

Submitted by Spirosure, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 13, 2019 after a review of 124 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. 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 Spirosure, Inc. devices

FDA 510(k) Submission Details - K182874

510(k) Number K182874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2018
Decision Date February 13, 2019
Days to Decision 124 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
36d slower than avg
Panel avg: 88d · This submission: 124d
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.

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All 11
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