Cleared Traditional

K853412 - WAVE GATE

K853412 is the FDA 510(k) clearance for WAVE GATE by Wolfline Corp.. It is a Class 2 Neurology device (product code GWE) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K853412 · Wolfline Corp. · Neurology device
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Oct 1985
Decision
76d
Days
Class 2
Risk

K853412 is an FDA 510(k) clearance for the WAVE GATE. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Wolfline Corp. (San Diego, US). The FDA issued a Cleared decision on October 28, 1985 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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.

View all Wolfline Corp. devices

Submission Details

510(k) Number K853412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1985
Decision Date October 28, 1985
Days to Decision 76 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 148d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 16
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K853412.
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
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MODIFIED BRAIN ATLAS III
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L.E.D. GOGGLES, MODEL 580-LEDGOG
K852533 · Bio-Logic Systems Corp. · Dec 1985
SLS 3500 LED VISUAL STIMULATOR
K842381 · Nihon Kohden America, Inc. · Nov 1984
BIOLOGIC SYSTEM BL 101
K831047 · Bio-Logic Systems Corp. · May 1983
STIMULATOR MODEL SSS-1101
K791149 · Nihon Kohden America, Inc. · Sep 1979