Cleared Traditional

K870795 - EMG ELECTRODES AND EXTENSION CORDS

K870795 is an FDA 510(k) clearance for EMG ELECTRODES AND EXTENSION CORDS, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K870795 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
15d
Days
Class 2
Risk

K870795 is an FDA 510(k) clearance for the EMG ELECTRODES AND EXTENSION CORDS. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K870795

510(k) Number K870795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date March 13, 1987
Days to Decision 15 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
133d faster than avg
Panel avg: 148d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKT Device Classification - Class 2, Special Controls

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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 - IKT Electrode, Needle, Diagnostic Electromyograph

All 8
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K870795.
NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE
K932059 · Dantec Medical, Inc. · Oct 1994
DANTEC DISPOSABLE CONCENTRIC NEEDLE
K931966 · Dantec Medical, Inc. · Mar 1994
DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12
K896874 · Dantec Medical, Inc. · Jun 1990
MEB-5200
K854664 · Nihon Kohden America, Inc. · Aug 1986