Cleared Traditional

K143607 - I-Portal NOTC, VNG and VOG (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143607 · Neuro Kinetics, Inc. · Ear, Nose, Throat device
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Jul 2015
Decision
201d
Days
Class 2
Risk

K143607 is an FDA 510(k) clearance for the I-Portal NOTC, VNG and VOG. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Neuro Kinetics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on July 8, 2015 after a review of 201 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 882.1460 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Neuro Kinetics, Inc. devices

Submission Details

510(k) Number K143607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2014
Decision Date July 08, 2015
Days to Decision 201 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 89d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - GWN Nystagmograph

All 58
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