Cleared Traditional

K151361 - Nox RIP Belts & Cables

K151361 is the FDA 510(k) clearance for Nox RIP Belts & Cables by Nox Medical Ehf. It is a Class 2 Anesthesiology device (product code MNR) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K151361 · Nox Medical Ehf · Anesthesiology device
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Nov 2015
Decision
169d
Days
Class 2
Risk

K151361 is an FDA 510(k) clearance for the Nox RIP Belts & Cables. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Nox Medical Ehf (Reykjavik, IS). The FDA issued a Cleared decision on November 6, 2015 after a review of 169 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.

View all Nox Medical Ehf devices

Submission Details

510(k) Number K151361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2015
Decision Date November 06, 2015
Days to Decision 169 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
29d slower than avg
Panel avg: 140d · This submission: 169d
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 62
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