Cleared Traditional

K864660 - MODEL M402 EMG MONITOR

K864660 is an FDA 510(k) clearance for MODEL M402 EMG MONITOR, manufactured by Bio-Logic Devices. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K864660 · Bio-Logic Devices · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
68d
Days
Class 2
Risk

K864660 is an FDA 510(k) clearance for the MODEL M402 EMG MONITOR. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Bio-Logic Devices (Deer Park, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 68 days - a notably fast clearance cycle.

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: 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 Bio-Logic Devices devices

FDA 510(k) Submission Details - K864660

510(k) Number K864660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1986
Decision Date February 04, 1987
Days to Decision 68 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 148d · This submission: 68d
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 43
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K864660.
PHASIS ELECTROMYOGRAPH
K922488 · Biosound, Inc. · Mar 1993
EMG NAVIGATOR & EMG TRAVELER
K893130 · Bio-Logic Systems Corp. · Mar 1990
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
CA2000
K842611 · Nicolet Biomedical Instruments · Jul 1984