Cleared Traditional

K152112 - VisualEyes

K152112 is an FDA 510(k) clearance for VisualEyes, manufactured by Interacoustics A/S. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K152112 · Interacoustics A/S · Neurology device
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Dec 2015
Decision
153d
Days
Class 2
Risk

K152112 is an FDA 510(k) clearance for the VisualEyes. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on December 29, 2015 after a review of 153 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Interacoustics A/S devices

FDA 510(k) Submission Details - K152112

510(k) Number K152112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2015
Decision Date December 29, 2015
Days to Decision 153 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 148d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWN Device Classification - Class 2, Special Controls

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 Neurology devices follow this clearance model.

Regulatory Peers - GWN Nystagmograph

All 32
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K152112.
I-Portal Neuro Otologic Test Center
K181025 · Neuro Kinetics, Inc. · Jul 2018
I-Portal Portable Assessment System - Nystagmograph (I-PAS)
K171884 · Neuro Kinetics, Inc. · Nov 2017
VisualEyes
K163149 · Interacoustics A/S · Apr 2017
EYESEECAM VHIT
K131681 · Interacoustics A/S · Sep 2013
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254 · Interacoustics A/S · Feb 2008
EXPRESSEYE
K992473 · Optomotor Laboratories · Aug 1999