Cleared Traditional

K912775 - SAPPHIRE 4ME EMG/EP SYSTEM

K912775 is an FDA 510(k) clearance for SAPPHIRE 4ME EMG/EP SYSTEM, manufactured by Medelec Intl. Corp.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K912775

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.

GWF Device Classification - Class 2, Special Controls

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 102
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K912775.
CADWELL SIERRA
K924723 · Cadwell Laboratories, Inc. · Mar 1993
DANTEC EVOLUTION
K924127 · Dantec Medical, 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
DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
K902607 · Dantec Medical, Inc. · May 1991
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K903731 · Teca, Inc. · Feb 1991