Cleared Traditional

K000870 - KM-10 TENS ELECTRODE

K000870 is an FDA 510(k) clearance for KM-10 TENS ELECTRODE, manufactured by Katecho, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K000870 · Katecho, Inc. · Neurology device
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Nov 2000
Decision
232d
Days
Class 2
Risk

K000870 is an FDA 510(k) clearance for the KM-10 TENS ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on November 7, 2000 after a review of 232 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.

FDA 510(k) Submission Details - K000870

510(k) Number K000870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2000
Decision Date November 07, 2000
Days to Decision 232 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
83d slower than avg
Panel avg: 149d · This submission: 232d
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 440
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K000870.
WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
K002219 · Wandy Rubber Industrial Co., Ltd. · Feb 2001
WANDY SILICONE CONDUCTIVE RUBBER PAD
K002227 · Wandy Rubber Industrial Co., Ltd. · Feb 2001
SOFTSENS
K001521 · Integrated Biosensing Technologies · Nov 2000
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
K001980 · Aspect Medical Systems, Inc. · Sep 2000
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
K002734 · Aspect Medical Systems, Inc. · Sep 2000
COMFORT STIM
K001117 · R & D Medical Products, Inc. · Jul 2000
K000870 · KM-10 TENS ELECTRODE
Download PDF Katecho, Inc.