Cleared Special

K120888 - PSG-1100 SLEEP DIAGNOSTIC SYSTEM

K120888 is an FDA 510(k) clearance for PSG-1100 SLEEP DIAGNOSTIC SYSTEM, manufactured by Nihon Kohden Corp.. The device is a Class 2 Neurology device with product code GWQ cleared through the Special 510(k) pathway after a 231-day FDA review.

K120888 · Nihon Kohden Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
231d
Days
Class 2
Risk

K120888 is an FDA 510(k) clearance for the PSG-1100 SLEEP DIAGNOSTIC SYSTEM. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Nihon Kohden Corp. (Foothill, US). The FDA issued a Cleared decision on November 9, 2012 after a review of 231 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 Corp. devices

FDA 510(k) Submission Details - K120888

510(k) Number K120888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2012
Decision Date November 09, 2012
Days to Decision 231 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
83d slower than avg
Panel avg: 148d · This submission: 231d
Pathway characteristics
Modification to existing cleared device.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 104
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K120888.
NeuroEEG
K173460 · Memory MD, Inc. · Feb 2018
Micromed BRAIN QUICK system
K171384 · Micromed S.P.A. · Feb 2018
Nihon Kohden Wireless Input Unit WEE-1200
K171124 · Nihon Kohden Corporation · Aug 2017
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
K113117 · Nihon Kohden America, Inc. · Mar 2012
ENTROPY EASYFIT SENSOR
K103129 · Ge Healthcare · Jul 2011
XLTEK EMU40 EEG HEADBOX, MODEL PK1072
K053386 · Excel Tech. , Ltd. · Apr 2006