Cleared Traditional

K850109 - NOMAD TM-3400

K850109 is the FDA 510(k) clearance for NOMAD TM-3400 by Tracor Northern, Inc.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K850109 · Tracor Northern, Inc. · Neurology device
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Jun 1985
Decision
141d
Days
Class 2
Risk

K850109 is an FDA 510(k) clearance for the NOMAD TM-3400. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Tracor Northern, Inc. (Middleton, US). The FDA issued a Cleared decision on June 4, 1985 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 K850109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date June 04, 1985
Days to Decision 141 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 148d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 51
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K850109.
TRAVELER LT
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