Cleared Traditional

K852587 - CDSA(COLOR DENSITY

K852587 is the FDA 510(k) clearance for CDSA(COLOR DENSITY by Tracor Northern, Inc.. It is a Class 2 Neurology device (product code OLT) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K852587 · Tracor Northern, Inc. · Neurology device
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Aug 1985
Decision
59d
Days
Class 2
Risk

K852587 is an FDA 510(k) clearance for the CDSA(COLOR DENSITY, SPECTRAL ARRRAY). 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 August 16, 1985 after a review of 59 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 Tracor Northern, Inc. devices

Submission Details

510(k) Number K852587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1985
Decision Date August 16, 1985
Days to Decision 59 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 148d · This submission: 59d
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 K852587.
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SLEEP STAGER
K850541 · Oxford Medilog, Inc. · Aug 1985
DUAL CHENNEL BRAIN ACTIVITY MONITOR
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OTE BIOMEDICA BERG FOURIER ANALYZER
K820653 · Del Mar Avionics · May 1982