Cleared Traditional

SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M (K960754) - FDA 510(k) Clearance

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

K960754 · Mecta Corp. · Neurology device
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Sep 1996
Decision
208d
Days
Class 2
Risk

K960754 is an FDA 510(k) clearance for the SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M. Classified as Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder (product code QGH), Class II - Special Controls.

Submitted by Mecta Corp. (Lake Oswego, US). The FDA issued a Cleared decision on September 18, 1996 after a review of 208 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5940 - 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.

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Submission Details

510(k) Number K960754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1996
Decision Date September 18, 1996
Days to Decision 208 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
60d slower than avg
Panel avg: 148d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5940
Definition Catatonia Or A Severe Major Depressive Episode (mde) Associated With Major Depressive Disorder (mdd) Or Bipolar Disorder (bpd) In Patients Age 13 Years And Older Who Are Treatment-resistant Or Who Require A Rapid Response Due To The Severity Of Their Psychiatric Or Medical Condition.
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.