Cleared Traditional

THYMATRON 2000 ELECTROCONVULSIVE SYSTEM (K945120) - FDA 510(k) Clearance

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

K945120 · Somatics, Inc. · Neurology device
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Oct 1995
Decision
372d
Days
Class 2
Risk

K945120 is an FDA 510(k) clearance for the THYMATRON 2000 ELECTROCONVULSIVE SYSTEM. Classified as Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder (product code QGH), Class II - Special Controls.

Submitted by Somatics, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on October 26, 1995 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Somatics, Inc. devices

Submission Details

510(k) Number K945120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1994
Decision Date October 26, 1995
Days to Decision 372 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
224d slower than avg
Panel avg: 148d · This submission: 372d
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.