Cleared Traditional

K112319 - ELECTRO-CAP SYSTEM

K112319 is the FDA 510(k) clearance for ELECTRO-CAP SYSTEM by Electro-Cap Intl., Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K112319 · Electro-Cap Intl., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
169d
Days
Class 2
Risk

K112319 is an FDA 510(k) clearance for the ELECTRO-CAP SYSTEM. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Electro-Cap Intl., Inc. (Eaton, US). The FDA issued a Cleared decision on January 27, 2012 after a review of 169 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 Electro-Cap Intl., Inc. devices

Submission Details

510(k) Number K112319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2011
Decision Date January 27, 2012
Days to Decision 169 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
21d slower than avg
Panel avg: 148d · This submission: 169d
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
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