Cleared Traditional

K860968 - TM-3400

K860968 is the FDA 510(k) clearance for 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 160-day FDA review.

K860968 · Tracor Northern, Inc. · Neurology device
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Aug 1986
Decision
160d
Days
Class 2
Risk

K860968 is an FDA 510(k) clearance for the TM-3400, NOMAD (MODIFIED). 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 August 18, 1986 after a review of 160 days - an extended review cycle.

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 K860968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1986
Decision Date August 18, 1986
Days to Decision 160 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 148d · This submission: 160d
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 K860968.
NOVAMETRIX MODEL 200 MAGSTIM
K871338 · Novametrix Medical Systems, Inc. · Aug 1987
EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
K863175 · Cadwell Laboratories, Inc. · Jan 1987
TRAVELER LT
K862690 · Bio-Logic Systems Corp. · Nov 1986
NEUROPACK 8, MEE-4108
K851300 · Nihon Kohden America, Inc. · Jun 1985
BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
K844992 · Bio-Logic Systems Corp. · Jun 1985
QUANTUM 84
K844707 · Cadwell Laboratories, Inc. · May 1985