Cleared Traditional

K844681 - EMG REPORT GENERATOR

K844681 is an FDA 510(k) clearance for EMG REPORT GENERATOR, manufactured by Microsystem Controls. The device is a Class 2 Neurology device with product code JXE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K844681 · Microsystem Controls · Neurology device
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Feb 1985
Decision
88d
Days
Class 2
Risk

K844681 is an FDA 510(k) clearance for the EMG REPORT GENERATOR. Classified as Device, Nerve Conduction Velocity Measurement (product code JXE), Class II - Special Controls.

Submitted by Microsystem Controls (Atlanta, US). The FDA issued a Cleared decision on February 26, 1985 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1550 - 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 Microsystem Controls devices

FDA 510(k) Submission Details - K844681

510(k) Number K844681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date February 26, 1985
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXE Device Classification - Class 2, Special Controls

Product Code JXE Device, Nerve Conduction Velocity Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1550
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 - JXE Device, Nerve Conduction Velocity Measurement

All 15
Devices cleared under the same product code (JXE) and FDA review panel - the closest regulatory comparables to K844681.
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
K963208 · Neurotron Medical · Jul 1997
REUSABLE DUAL DISC BAR RECORDING ELECTRODES
K923665 · Chalgren Enterprises, Inc. · Oct 1992
REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS
K921504 · Chalgren Enterprises, Inc. · Sep 1992
CADWELL 5200
K820031 · Cadwell Laboratories, Inc. · Feb 1982