Cleared Traditional

K100661 - EARPROBE

K100661 is an FDA 510(k) clearance for EARPROBE, manufactured by Path Medical GmbH. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K100661 · Path Medical GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Path Medical GmbH devices

FDA 510(k) Submission Details - K100661

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
34d faster than avg
Panel avg: 149d · This submission: 115d
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 54
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K100661.
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ICS CHARTR EP 200
K083399 · Gn Otometrics A/S · Feb 2009