Cleared Traditional

K100661 - EARPROBE (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100661 · Path Medical GmbH · Neurology device
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Jul 2010
Decision
115d
Days
Class 2
Risk

K100661 is an FDA 510(k) clearance for the EARPROBE. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Path Medical GmbH (Fort Collins, US). The FDA issued a Cleared decision on July 1, 2010 after a review of 115 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.

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Submission Details

510(k) Number K100661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2010
Decision Date July 01, 2010
Days to Decision 115 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 148d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.