Cleared Traditional

K955597 - MEDI-TRACE DEFIB PADS

K955597 is an FDA 510(k) clearance for MEDI-TRACE DEFIB PADS, manufactured by Graphic Controls Corp.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 214-day FDA review.

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

FDA 510(k) Submission Details - K955597

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
Combination Product No
PCCP Authorized No
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.

GYB Device Classification - Class 2, Special Controls

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 28
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