Cleared Traditional

K072254 - VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM

K072254 is an FDA 510(k) clearance for VN415M, 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 175-day FDA review.

K072254 · Interacoustics A/S · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
175d
Days
Class 2
Risk

K072254 is an FDA 510(k) clearance for the VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Interacoustics A/S (Minnesota, US). The FDA issued a Cleared decision on February 5, 2008 after a review of 175 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.

FDA 510(k) Submission Details - K072254

510(k) Number K072254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2007
Decision Date February 05, 2008
Days to Decision 175 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
26d slower than avg
Panel avg: 149d · This submission: 175d
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 K072254.
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K072254 · VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
Download PDF FDA Summary Interacoustics A/S