Cleared Special

K080546 - NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K080546 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
183d
Days
Class 2
Risk

K080546 is an FDA 510(k) clearance for the NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on August 29, 2008 after a review of 183 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K080546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2008
Decision Date August 29, 2008
Days to Decision 183 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 148d · This submission: 183d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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 - OLT Non-normalizing Quantitative Electroencephalograph Software

All 53
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K080546.
HippoMind (v1.0)
K251881 · Hippoclinic · Dec 2025
EEG-1260A Neurofax System (EEG-1260A)
K251366 · Nihon Kohden Corporation · Oct 2025
VEEGix EEG System
K240593 · Neuroservo, Inc. · Aug 2024
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K220254 · Neurosoft , Ltd. · Nov 2022
Wireless EEG System
K213299 · Pascall Systems, Inc. · May 2022