Cleared Traditional

K955597 - MEDI-TRACE DEFIB PADS (FDA 510(k) Clearance)

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

K955597 · Graphic Controls Corp. · Neurology device
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Jul 1996
Decision
214d
Days
Class 2
Risk

K955597 is an FDA 510(k) clearance for the MEDI-TRACE DEFIB PADS. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Buafflo, US). The FDA issued a Cleared decision on July 9, 1996 after a review of 214 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 Graphic Controls Corp. devices

Submission Details

510(k) Number K955597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1995
Decision Date July 09, 1996
Days to Decision 214 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
66d slower than avg
Panel avg: 148d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 68
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