Cleared Special

NEUROFAX, MODELS EEG-1100A, EEG-9100A (K011204) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011204 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
19d
Days
Class 2
Risk

K011204 is an FDA 510(k) clearance for the NEUROFAX, MODELS EEG-1100A, EEG-9100A. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on May 8, 2001 after a review of 19 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

Submission Details

510(k) Number K011204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2001
Decision Date May 08, 2001
Days to Decision 19 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
129d faster than avg
Panel avg: 148d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OLV Standard Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.
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 - OLV Standard Polysomnograph With Electroencephalograph

All 18
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K011204.
ELECTRODE JUNCTION BOX, MODEL JE-921A
K050833 · Nihon Kohden America, Inc. · Apr 2005
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
K033475 · Nihon Kohden America, Inc. · Jan 2004
PSG INPUT BOX, MODEL JE-912AK
K022121 · Nihon Kohden America, Inc. · Jul 2002
VITAPORT 3
K000338 · Nihon Kohden America, Inc. · Apr 2000
NEUROFAX, MODEL EEG-1100A
K992742 · Nihon Kohden America, Inc. · Oct 1999
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
K983072 · Nihon Kohden America, Inc. · Dec 1998