Cleared Traditional

K124062 - QDC-PRO

K124062 is the FDA 510(k) clearance for QDC-PRO by Nox Medical. It is a Class 2 Anesthesiology device (product code MNR) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K124062 · Nox Medical · Anesthesiology device
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Jul 2013
Decision
191d
Days
Class 2
Risk

K124062 is an FDA 510(k) clearance for the QDC-PRO, AND NOX-RIP. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Nox Medical (Reykjavik, IS). The FDA issued a Cleared decision on July 10, 2013 after a review of 191 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K124062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2012
Decision Date July 10, 2013
Days to Decision 191 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 140d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 61
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