Cleared Traditional

K193033 - GSI Audera Pro

K193033 is the FDA 510(k) clearance for GSI Audera Pro by Grason Stadler. It is a Class 2 Neurology device (product code GWJ) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K193033 · Grason Stadler · Neurology device
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Apr 2020
Decision
176d
Days
Class 2
Risk

K193033 is an FDA 510(k) clearance for the GSI Audera Pro. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Grason Stadler (Eden Prairie, US). The FDA issued a Cleared decision on April 24, 2020 after a review of 176 days - an extended review 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: 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 Grason Stadler devices

Submission Details

510(k) Number K193033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2019
Decision Date April 24, 2020
Days to Decision 176 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
28d slower than avg
Panel avg: 148d · This submission: 176d
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.

Regulatory Consultant

Kamm & Associates
Daniel Kamm

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWJ Stimulator, Auditory, Evoked Response

All 7
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