Cleared Traditional

K131681 - EYESEECAM VHIT

K131681 is an FDA 510(k) clearance for EYESEECAM VHIT, 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 88-day FDA review.

K131681 · Interacoustics A/S · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
88d
Days
Class 2
Risk

K131681 is an FDA 510(k) clearance for the EYESEECAM VHIT. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on September 6, 2013 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K131681

510(k) Number K131681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2013
Decision Date September 06, 2013
Days to Decision 88 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
61d faster than avg
Panel avg: 149d · This submission: 88d
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 55
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K131681.
VisualEyes
K152112 · Interacoustics A/S · Dec 2015
ICS Impulse
K151504 · Gn Otometrics · Nov 2015
I-Portal NOTC, VNG and VOG
K143607 · Neuro Kinetics, Inc. · Jul 2015
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
K130201 · Ototronix, LLC · Apr 2013
ICS IMPULSE
K122550 · Gn Otometrics · Feb 2013
I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL
K083603 · Neuro Kinetics · Aug 2009
K131681 · EYESEECAM VHIT
Download PDF FDA Summary Interacoustics A/S