Cleared Traditional

K082113 - NOX T3, NOXTURNAL (PC APPLICATION)

K082113 is an FDA 510(k) clearance for NOX T3, manufactured by Nox Medical. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K082113 · Nox Medical · Anesthesiology device
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Nov 2008
Decision
102d
Days
Class 2
Risk

K082113 is an FDA 510(k) clearance for the NOX T3, NOXTURNAL (PC APPLICATION). 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 November 7, 2008 after a review of 102 days - within the typical 510(k) review window.

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 devices

FDA 510(k) Submission Details - K082113

510(k) Number K082113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2008
Decision Date November 07, 2008
Days to Decision 102 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
38d faster than avg
Panel avg: 140d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

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 110
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K082113.
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GALAXY
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FLOCHANNEL
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CADWELL EASYNET NASAL PRESSURE MODULE
K061705 · Cadwell Laboratories, Inc. · Nov 2006
STARDUST II
K052573 · Respironics, Inc. · Dec 2005