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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Maico-Diagnostics devices

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
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 20
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K082035.
QScreen
K220139 · Path Medical GmbH · Aug 2022
ALGO 7i
K211147 · Path Medical GmbH · Oct 2021
GSI Audera Pro
K193033 · Grason Stadler · Apr 2020
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626 · Bio-Logic Systems Corp. · Feb 2008
STACKED ABR FOR NAVIGATOR PRO
K030907 · Bio-Logic Systems Corp. · May 2003
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
K031009 · Bio-Logic Systems Corp. · Apr 2003