Cleared Traditional

K874733 - GUARDIAN

K874733 is the FDA 510(k) clearance for GUARDIAN by Tracor Northern, Inc.. It is a Class 2 Neurology device (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

Submission Details

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.

Device Classification

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 16
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K874733.
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
K000892 · Datex-Ohmeda, Inc. · Jun 2000
SIEMENS INFINITY EEG POD
K991012 · Siemens Medical Solutions USA, Inc. · Jun 1999
TOPOGRAPHIC BRAIN MAPPING OPTION
K934050 · Biosound, Inc. · Feb 1994
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