Cleared Traditional

K011746 - MB 11

K011746 is an FDA 510(k) clearance for MB 11, manufactured by Maico Diagnostic GmbH. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K011746 · Maico Diagnostic GmbH · Neurology device
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Aug 2001
Decision
79d
Days
Class 2
Risk

K011746 is an FDA 510(k) clearance for the MB 11. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Maico Diagnostic GmbH (Eden Prairie, US). The FDA issued a Cleared decision on August 24, 2001 after a review of 79 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.

FDA 510(k) Submission Details - K011746

510(k) Number K011746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2001
Decision Date August 24, 2001
Days to Decision 79 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
70d faster than avg
Panel avg: 149d · This submission: 79d
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 75
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K011746.
SABRE COMPAC
K011842 · Sle Limited · Jan 2002
AURIS AEP
K012415 · Synapsys, Inc. · Dec 2001
ALGO 3 NEWBORN HEARING SCREENER
K013137 · Natus Medical, Inc. · Oct 2001
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
K002985 · Ics Medical Corp. · Dec 2000
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149 · Bio-Logic Systems Corp. · Dec 1999
SABRE
K993177 · Sle Limited · Nov 1999
K011746 · MB 11
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