Cleared Traditional

K082035 - MAICO MB 11 WITH BERAPHONE PROBE

K082035 is an FDA 510(k) clearance for MAICO MB 11 WITH BERAPHONE PROBE, manufactured by Maico-Diagnostics. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K082035 · Maico-Diagnostics · Neurology device
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Jan 2009
Decision
196d
Days
Class 2
Risk

K082035 is an FDA 510(k) clearance for the MAICO MB 11 WITH BERAPHONE PROBE. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Maico-Diagnostics (Minnesota, US). The FDA issued a Cleared decision on January 29, 2009 after a review of 196 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.

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FDA 510(k) Submission Details - K082035

510(k) Number K082035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2008
Decision Date January 29, 2009
Days to Decision 196 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 148d · This submission: 196d
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 48
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K082035.
ICS CHARTR EP 200
K092373 · Gn Otometrics · Sep 2009
SMARTSCREENER-PLUS2
K090579 · Intelligent Hearing Systems · Jul 2009
ICS CHARTR EP 200
K083399 · Gn Otometrics A/S · Feb 2009
VIVOSONIC NEUROSCREEN
K080060 · Vivosonic, Inc. · Apr 2008
SMART COUPLER, MODEL M015401
K073384 · Intelligent Hearing Systems · Feb 2008
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626 · Bio-Logic Systems Corp. · Feb 2008