Cleared Traditional

K131141 - EARPROBE

K131141 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 65-day FDA review.

K131141 · Path Medical GmbH · Neurology device
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Jun 2013
Decision
65d
Days
Class 2
Risk

K131141 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 (Germering, Bavaria, DE). The FDA issued a Cleared decision on June 27, 2013 after a review of 65 days - a notably fast clearance cycle.

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: 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 Path Medical GmbH devices

FDA 510(k) Submission Details - K131141

510(k) Number K131141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2013
Decision Date June 27, 2013
Days to Decision 65 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
84d faster than avg
Panel avg: 149d · This submission: 65d
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 K131141.
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