Cleared Traditional

K092573 - NIHON KOHDEN QP-160AK EEG TREND PROGRAM (FDA 510(k) Clearance)

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

K092573 · Nihon Kohden America, Inc. · Neurology device
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Jul 2010
Decision
323d
Days
Class 2
Risk

K092573 is an FDA 510(k) clearance for the NIHON KOHDEN QP-160AK EEG TREND PROGRAM. Classified as Amplitude-integrated Electroencephalograph (product code OMA), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on July 9, 2010 after a review of 323 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 K092573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2009
Decision Date July 09, 2010
Days to Decision 323 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
175d slower than avg
Panel avg: 148d · This submission: 323d
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.