Cleared Traditional

ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 (K860467) - FDA 510(k) Clearance

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

K860467 · Medcraft Corp. · Neurology device
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Nov 1986
Decision
277d
Days
Class 2
Risk

K860467 is an FDA 510(k) clearance for the ELECTROSHOCK UNIT NEUROLOGY MODEL B-25. Classified as Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder (product code QGH), Class II - Special Controls.

Submitted by Medcraft Corp. (Darien, US). The FDA issued a Cleared decision on November 10, 1986 after a review of 277 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.

View all Medcraft Corp. devices

Submission Details

510(k) Number K860467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1986
Decision Date November 10, 1986
Days to Decision 277 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 148d · This submission: 277d
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.

Regulatory Peers - QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Devices cleared under the same product code (QGH) and FDA review panel - the closest regulatory comparables to K860467.
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