Cleared Traditional

K130238 - NIHON KOHDEN AE-918P NEURO UNIT (FDA 510(k) Clearance)

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

K130238 · Nihon Kohden Corp. · Neurology device
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Mar 2015
Decision
762d
Days
Class 2
Risk

K130238 is an FDA 510(k) clearance for the NIHON KOHDEN AE-918P NEURO UNIT. Classified as Amplitude-integrated Electroencephalograph (product code OMA), Class II - Special Controls.

Submitted by Nihon Kohden Corp. (San Diego, US). The FDA issued a Cleared decision on March 4, 2015 after a review of 762 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Nihon Kohden Corp. devices

Submission Details

510(k) Number K130238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2013
Decision Date March 04, 2015
Days to Decision 762 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
614d slower than avg
Panel avg: 148d · This submission: 762d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMA Amplitude-integrated Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner).
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.