Cleared Traditional

K962283 - EEG ELECTRODES

K962283 is an FDA 510(k) clearance for EEG ELECTRODES, manufactured by Teca, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K962283 · Teca, Inc. · Neurology device
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Dec 1996
Decision
186d
Days
Class 2
Risk

K962283 is an FDA 510(k) clearance for the EEG ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Teca, Inc. (Pleasantiville, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 186 days - an extended review cycle.

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. 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 Teca, Inc. devices

FDA 510(k) Submission Details - K962283

510(k) Number K962283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1996
Decision Date December 16, 1996
Days to Decision 186 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
38d slower than avg
Panel avg: 148d · This submission: 186d
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 320
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K962283.
VALUETRODE
K970426 · Axelgaard Mfg. Co., Ltd. · May 1997
MEDICOM, TENS ELECTRODES
K965194 · Medicotest A/S · Mar 1997
AQUABOND ELECTRODE
K964433 · Medibond , Ltd. · Jan 1997
M & R DISPOSABLE ELECTRODE (14200)
K963236 · M & R Mfg., Inc. · Nov 1996
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
K961821 · Aspect Medical Systems, Inc. · Oct 1996
EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
K961141 · Uni-Patch, Inc. · May 1996