Cleared Traditional

K874733 - GUARDIAN, EEG BRAIN MONITORING SYSTEM

K874733 is an FDA 510(k) clearance for GUARDIAN, manufactured by Tracor Northern, Inc.. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K874733 · Tracor Northern, Inc. · Neurology device
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Feb 1988
Decision
103d
Days
Class 2
Risk

K874733 is an FDA 510(k) clearance for the GUARDIAN, EEG BRAIN MONITORING SYSTEM. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Tracor Northern, Inc. (Middleton, US). The FDA issued a Cleared decision on February 29, 1988 after a review of 103 days - within the typical 510(k) review window.

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: 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 Tracor Northern, Inc. devices

FDA 510(k) Submission Details - K874733

510(k) Number K874733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date February 29, 1988
Days to Decision 103 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 148d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A 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 - OLT Non-normalizing Quantitative Electroencephalograph Software

All 35
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K874733.
SPECTRAL EEG MONITOR MODEL A1000
K923043 · Aspect Medical Systems, Inc. · Dec 1992
TECA NEUROMAPPER 386
K894889 · Teca, Inc. · Dec 1989
TECA NEUROMAPPER 1620, BRAIN MAPPER
K894088 · Teca, Inc. · Nov 1989
SLEEP STAGER
K850541 · Oxford Medilog, Inc. · Aug 1985
DUAL CHENNEL BRAIN ACTIVITY MONITOR
K843808 · Datex Division Instrumentarium Corp. · Nov 1984
OTE BIOMEDICA BERG FOURIER ANALYZER
K820653 · Del Mar Avionics · May 1982