Cleared Traditional

RUB E-Z (K854396) - FDA 510(k) Clearance

Class I Neurology device.

K854396 · E-Z Instruments Co. · Neurology device
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May 1986
Decision
189d
Days
Class 1
Risk

K854396 is an FDA 510(k) clearance for the RUB E-Z. Classified as Tester, Electrode/lead, Electroencephalograph (product code GYA), Class I - General Controls.

Submitted by E-Z Instruments Co. (San Antonio, US). The FDA issued a Cleared decision on May 8, 1986 after a review of 189 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1410 - 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 E-Z Instruments Co. devices

Submission Details

510(k) Number K854396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1985
Decision Date May 08, 1986
Days to Decision 189 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 148d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GYA Tester, Electrode/lead, Electroencephalograph
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.