Cleared Traditional

K941568 - K-10-VS

K941568 is the FDA 510(k) clearance for K-10-VS by Medicotest, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K941568 · Medicotest, Inc. · Neurology device
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Nov 1994
Decision
218d
Days
Class 2
Risk

K941568 is an FDA 510(k) clearance for the K-10-VS, DA-05-VS, RECORDING ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medicotest, Inc. (Dk3650 Olstykke, DK). The FDA issued a Cleared decision on November 4, 1994 after a review of 218 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 Medicotest, Inc. devices

Submission Details

510(k) Number K941568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1994
Decision Date November 04, 1994
Days to Decision 218 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 148d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 153
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K941568.
CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS
K944603 · Conmedcorp · Dec 1994
SMARTBRACE ELECTRODE
K940012 · Medical Devices, Inc. · Dec 1994
ELECTROFLEX
K943126 · Medical Devices, Inc. · Dec 1994
ELECTRODE, CUTANEOUS
K933801 · Cadwell Laboratories, Inc. · Oct 1994
CUTANEOUS ELECTRODE
K933802 · Cadwell Laboratories, Inc. · Sep 1994
GROUND PLATE ELECTRODE
K933807 · Cadwell Laboratories, Inc. · Jul 1994