Cleared Traditional

K893130 - EMG NAVIGATOR & EMG TRAVELER

K893130 is an FDA 510(k) clearance for EMG NAVIGATOR & EMG TRAVELER, manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K893130 · Bio-Logic Systems Corp. · Neurology device
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Mar 1990
Decision
329d
Days
Class 2
Risk

K893130 is an FDA 510(k) clearance for the EMG NAVIGATOR & EMG TRAVELER. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on March 20, 1990 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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. Elevated predicate reliance profile. 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 Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K893130

510(k) Number K893130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1989
Decision Date March 20, 1990
Days to Decision 329 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 148d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 22
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K893130.
EXCEL EMG
K941144 · Excel Tech. , Ltd. · Nov 1995
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
K930328 · Bio-Logic Systems Corp. · Jul 1993
PHASIS ELECTROMYOGRAPH
K922488 · Biosound, Inc. · Mar 1993
MODIFIED NICOLET VIKING SYSTEM
K880573 · Nicolet Biomedical Instruments · Mar 1988
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · Chattanooga Group, Inc. · Dec 1986
NICOLET VIKING
K842956 · Nicolet Biomedical Instruments · Aug 1984