Cleared Traditional

K123701 - HEARLAB ACA

K123701 is an FDA 510(k) clearance for HEARLAB ACA, manufactured by Frye Electronics, Inc.. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K123701 · Frye Electronics, Inc. · Neurology device
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Apr 2013
Decision
123d
Days
Class 2
Risk

K123701 is an FDA 510(k) clearance for the HEARLAB ACA. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Frye Electronics, Inc. (Tigard, US). The FDA issued a Cleared decision on April 5, 2013 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - 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 Frye Electronics, Inc. devices

FDA 510(k) Submission Details - K123701

510(k) Number K123701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2012
Decision Date April 05, 2013
Days to Decision 123 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 148d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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 - GWJ Stimulator, Auditory, Evoked Response

All 32
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K123701.
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TITAN
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