Cleared Traditional

GED (GRADUATED ELECTRONIC DECELERATOR (K911820) - FDA 510(k) Clearance

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

K911820 · Behavior Research Institute, Inc. · Neurology device
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Dec 1994
Decision
1321d
Days
Class 2
Risk

K911820 is an FDA 510(k) clearance for the GED (GRADUATED ELECTRONIC DECELERATOR. Classified as Device, Aversive Conditioning (product code HCB), Class II - Special Controls.

Submitted by Behavior Research Institute, Inc. (Providence, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 1321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5235 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Behavior Research Institute, Inc. devices

Submission Details

510(k) Number K911820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1991
Decision Date December 05, 1994
Days to Decision 1321 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
1173d slower than avg
Panel avg: 148d · This submission: 1321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCB Device, Aversive Conditioning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5235
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.