Cleared Traditional

K870450 - SZAC-16 SEIZURE ANALYSIS COMPUTER

K870450 is the FDA 510(k) clearance for SZAC-16 SEIZURE ANALYSIS COMPUTER by Grass-Telefactor Product Group. It is a Class 2 Neurology device (product code OMB) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K870450 · Grass-Telefactor Product Group · Neurology device
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Apr 1987
Decision
64d
Days
Class 2
Risk

K870450 is an FDA 510(k) clearance for the SZAC-16 SEIZURE ANALYSIS COMPUTER. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by Grass-Telefactor Product Group (W. Conshohocken, US). The FDA issued a Cleared decision on April 8, 1987 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 K870450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date April 08, 1987
Days to Decision 64 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 148d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMB Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User
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 - OMB Automatic Event Detection Software For Full-montage Electroencephalograph

All 23
Devices cleared under the same product code (OMB) and FDA review panel - the closest regulatory comparables to K870450.
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
K010085 · Excel Tech. , Ltd. · Mar 2001
EEG SPIKE AND EVENT DETECTOR MODULE
K002332 · Excel Tech. , Ltd. · Oct 2000
BIO-LOGIC AUTOMATIC EVENT ANALYSIS
K951594 · Bio-Logic Systems Corp. · Aug 1995