Cleared Traditional

K982053 - EEG ELECTRODES MODEL 445 SERIES

K982053 is an FDA 510(k) clearance for EEG ELECTRODES MODEL 445 SERIES, manufactured by Class A Ent.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K982053 · Class A Ent. · Neurology device
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Apr 1999
Decision
313d
Days
Class 2
Risk

K982053 is an FDA 510(k) clearance for the EEG ELECTRODES MODEL 445 SERIES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Class A Ent. (Yucca Valley, US). The FDA issued a Cleared decision on April 20, 1999 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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. Elevated predicate reliance profile. 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 Class A Ent. devices

FDA 510(k) Submission Details - K982053

510(k) Number K982053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1998
Decision Date April 20, 1999
Days to Decision 313 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
165d slower than avg
Panel avg: 148d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 242
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K982053.
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330 · Aspect Medical Systems, Inc. · Jan 2000
TENS/FES/NMES ELECTRODES
K983097 · Uni-Patch, Inc. · Sep 1999
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO
K982096 · Rapid Mfg. Co. · Jun 1999
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
K983741 · Axelgaard Mfg. Co., Ltd. · Dec 1998
SLE ELECTRODES AND ACCESSORIES
K980410 · Specialized Laboratory Equipment, Ltd. · Oct 1998
TECA NCS ELECTRODE SYSTEM 2000
K971914 · Medelec, Inc. D.B.A. Teca Corp. · Mar 1998