Cleared Traditional

K062198 - SUNSPOTS PRE-GELLED SURFACE ELECTRODES (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062198 · Axon Systems, Inc. · Neurology device
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Dec 2006
Decision
140d
Days
Class 2
Risk

K062198 is an FDA 510(k) clearance for the SUNSPOTS PRE-GELLED SURFACE ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Axon Systems, Inc. (Hauppauge, US). The FDA issued a Cleared decision on December 19, 2006 after a review of 140 days - within the typical 510(k) review window.

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 Axon Systems, Inc. devices

Submission Details

510(k) Number K062198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2006
Decision Date December 19, 2006
Days to Decision 140 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 148d · This submission: 140d
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 433
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