Cleared Traditional

STD-228 SPECTRAL TREND DISPLAY (K871480) - FDA 510(k) Clearance

Class I Neurology device.

K871480 · Grass-Telefactor Product Group · Neurology device
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May 1987
Decision
17d
Days
Class 1
Risk

K871480 is an FDA 510(k) clearance for the STD-228 SPECTRAL TREND DISPLAY. Classified as Analyzer, Spectrum, Electroencephalogram Signal (product code GWS), Class I - General Controls.

Submitted by Grass-Telefactor Product Group (W. Conshohocken, US). The FDA issued a Cleared decision on May 1, 1987 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1420 - 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 Grass-Telefactor Product Group devices

Submission Details

510(k) Number K871480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1987
Decision Date May 01, 1987
Days to Decision 17 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 148d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GWS Analyzer, Spectrum, Electroencephalogram Signal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1420
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.