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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 149d · 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 164
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