Cleared Traditional

MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER (K870794) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870794 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1987
Decision
216d
Days
Class 2
Risk

K870794 is an FDA 510(k) clearance for the MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on September 30, 1987 after a review of 216 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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 Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K870794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date September 30, 1987
Days to Decision 216 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
68d slower than avg
Panel avg: 148d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 14
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K870794.
8-CH Electroencephalography Amplifier
K201747 · Hipposcreen Neurotech Corp. · Dec 2020
eego amplifiers
K172312 · Eemagine Medical Imaging Solutions GmbH · Mar 2018
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177 · Nihon Kohden America, Inc. · Sep 1988
NEUROPACK II 5100
K841612 · Nihon Kohden America, Inc. · Jun 1984