Cleared Traditional

K092573 - NIHON KOHDEN QP-160AK EEG TREND PROGRAM

K092573 is an FDA 510(k) clearance for NIHON KOHDEN QP-160AK EEG TREND PROGRAM, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code OMA cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K092573 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K092573

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
Combination Product No
PCCP Authorized No
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.

OMA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - OMA Amplitude-integrated Electroencephalograph

Devices cleared under the same product code (OMA) and FDA review panel - the closest regulatory comparables to K092573.
Neo
K192889 · Eemagine Medical Imaging Solutions GmbH · Jan 2020
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
K120485 · Nihon Kohden America, Inc. · Mar 2012
OLYMPIC CFM 6000
K031149 · Olympic Medical Corp. · May 2003
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
K983229 · Olympic Medical Corp. · Mar 1999