Cleared Special

K120485 - NIHON KOHDEN QP-160 AK TREND PROGRAM WI...

K120485 is an FDA 510(k) clearance for NIHON KOHDEN QP-160 AK TREND PROGRAM WI..., manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code OMA cleared through the Special 510(k) pathway after a 28-day FDA review.

K120485 · Nihon Kohden America, Inc. · Neurology device
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Mar 2012
Decision
28d
Days
Class 2
Risk

K120485 is an FDA 510(k) clearance for the NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND.... 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 March 16, 2012 after a review of 28 days - a notably fast clearance 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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K120485

510(k) Number K120485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2012
Decision Date March 16, 2012
Days to Decision 28 days
Submission Type Special
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
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K120485.
Neo
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