Cleared Traditional

K974385 - MLS ELECTROMYOGRAPHIC PREAMPLIFIER

K974385 is an FDA 510(k) clearance for MLS ELECTROMYOGRAPHIC PREAMPLIFIER, manufactured by Motion Lab Systems, Inc.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974385 · Motion Lab Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
90d
Days
Class 2
Risk

K974385 is an FDA 510(k) clearance for the MLS ELECTROMYOGRAPHIC PREAMPLIFIER. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Motion Lab Systems, Inc. (Baton Rouge, US). The FDA issued a Cleared decision on February 19, 1998 after a review of 90 days - within the typical 510(k) review window.

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. 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 Motion Lab Systems, Inc. devices

FDA 510(k) Submission Details - K974385

510(k) Number K974385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date February 19, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 27
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K974385.
NIM-PRS
K024316 · Medtronic Xomed, Inc. · Jan 2003
NEUROPACK MICRO, MODEL MED-9100A SERIES
K010590 · Nihon Kohden America, Inc. · Jun 2001
TOENNIES NEUROSCREEN SYSTEM
K972419 · Erich Jaeger, Inc. · Apr 1998
ADVANTAGE EMG SYSTEM, MODEL #A100
K974010 · Advantage Medical Division of Cme Telemetrix · Jan 1998
ADVANTAGE 3000
K973355 · Advantage Medical Division of Cme Telemetrix · Dec 1997
EXCEL EMG
K941144 · Excel Tech. , Ltd. · Nov 1995