Cleared Traditional

K912775 - SAPPHIRE 4ME EMG/EP SYSTEM

K912775 is the FDA 510(k) clearance for SAPPHIRE 4ME EMG/EP SYSTEM by Medelec Intl. Corp.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K912775 · Medelec Intl. Corp. · Neurology device
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Nov 1991
Decision
137d
Days
Class 2
Risk

K912775 is an FDA 510(k) clearance for the SAPPHIRE 4ME EMG/EP SYSTEM. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Medelec Intl. Corp. (England, GB). The FDA issued a Cleared decision on November 8, 1991 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Medelec Intl. Corp. devices

Submission Details

510(k) Number K912775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1991
Decision Date November 08, 1991
Days to Decision 137 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
11d faster than avg
Panel avg: 148d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 51
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K912775.
CADWELL 6200 A
K931428 · Cadwell Laboratories, Inc. · Jun 1993
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K924723 · Cadwell Laboratories, Inc. · Mar 1993
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
K912685 · Nihon Kohden America, Inc. · Feb 1992
HIGH SPEED MAGNETIC STIMULATOR
K905059 · Cadwell Laboratories, Inc. · Sep 1991
MEM-7102
K890274 · Nihon Kohden America, Inc. · May 1989
CADWELL EXCEL
K880088 · Cadwell Laboratories, Inc. · May 1988