Cleared Traditional

ELECTRODE IMPEDANCE TESTER-MODEL 500 (K781475) - FDA 510(k) Clearance

Class I Neurology device.

K781475 · Life-Tech Instruments, Inc. · Neurology device
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Sep 1978
Decision
10d
Days
Class 1
Risk

K781475 is an FDA 510(k) clearance for the ELECTRODE IMPEDANCE TESTER-MODEL 500. Classified as Tester, Electrode/lead, Electroencephalograph (product code GYA), Class I - General Controls.

Submitted by Life-Tech Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1978 after a review of 10 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Life-Tech Instruments, Inc. devices

Submission Details

510(k) Number K781475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1978
Decision Date September 07, 1978
Days to Decision 10 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 148d · This submission: 10d
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.