Cleared Traditional

EPISON, ALERTING SYSTEM FOR EPILEPTICS (K862766) - FDA 510(k) Clearance

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

K862766 · Zygo Industries, Inc. · Neurology device
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Mar 1987
Decision
234d
Days
Class 2
Risk

K862766 is an FDA 510(k) clearance for the EPISON, ALERTING SYSTEM FOR EPILEPTICS. Classified as Device, Sleep Assessment (product code LEL), Class II - Special Controls.

Submitted by Zygo Industries, Inc. (Portland, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 234 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 Zygo Industries, Inc. devices

Submission Details

510(k) Number K862766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1986
Decision Date March 13, 1987
Days to Decision 234 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 148d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LEL Device, Sleep Assessment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - LEL Device, Sleep Assessment

All 18
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