Cleared Traditional

K850646 - ECLIPSE SELF ADHERING ELECTRODE

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

K850646 · Todd Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K850646

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.

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 318
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K850646.
ULTRAHESIVE II POSTOP ELECTRODE
K862028 · Medical Devices, Inc. · Aug 1986
JELTRODE
K861956 · Henley Intl. · Jun 1986
EMPI, NMS/SUE CUTANEOUS ELECTRODE
K854513 · Empi · Dec 1985
TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE
K851175 · Medical Devices, Inc. · Jun 1985
COMFORT-EASE ELECTRODE
K851303 · Medtronic Vascular · May 1985
EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
K850108 · Nicolet Biomedical Instruments · Apr 1985