Cleared Special

K021215 - BIO-LOGIC ABAER CUB

K021215 is an FDA 510(k) clearance for BIO-LOGIC ABAER CUB, manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Neurology device with product code GWJ cleared through the Special 510(k) pathway after a 28-day FDA review.

K021215 · Bio-Logic Systems Corp. · Neurology device
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May 2002
Decision
28d
Days
Class 2
Risk

K021215 is an FDA 510(k) clearance for the BIO-LOGIC ABAER CUB. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on May 15, 2002 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K021215

510(k) Number K021215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2002
Decision Date May 15, 2002
Days to Decision 28 days
Submission Type Special
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
121d faster than avg
Panel avg: 149d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K021215.
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
K031009 · Bio-Logic Systems Corp. · Apr 2003
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895 · Bio-Logic Systems Corp. · Jul 2002
ECHO-SCREEN T, TA, TD, TDA, TC
K013977 · Fischer-Zoth Audiologic Systems, Inc. · Jun 2002
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