Cleared Traditional

K850646 - ECLIPSE SELF ADHERING ELECTRODE

K850646 is the FDA 510(k) clearance for ECLIPSE SELF ADHERING ELECTRODE by Todd Medical, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K850646 · Todd Medical, Inc. · Neurology device
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Sep 1985
Decision
196d
Days
Class 2
Risk

K850646 is an FDA 510(k) clearance for the ECLIPSE SELF ADHERING ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Todd Medical, Inc. (N Canton, US). The FDA issued a Cleared decision on September 3, 1985 after a review of 196 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 Todd Medical, Inc. devices

Submission Details

510(k) Number K850646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date September 03, 1985
Days to Decision 196 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 148d · This submission: 196d
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 107
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K850646.
TENZCARE SNAP ELECTRODE, NO. 6865
K863307 · 3M Company · Sep 1986
POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER
K863035 · Valleylab, Inc. · Sep 1986
VERSA STIM
K862718 · Conmedcorp · Sep 1986
COMFORT-EASE ELECTRODE
K851303 · Medtronic Vascular · May 1985
CANMED 103
K844098 · Medtronic Vascular · Feb 1985
CANMED 103 9300 ELECTRODE
K844097 · Medtronic Vascular · Dec 1984