Cleared Special

K011204 - NEUROFAX

K011204 is an FDA 510(k) clearance for NEUROFAX, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code OLV cleared through the Special 510(k) pathway after a 19-day FDA review.

K011204 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K011204

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.

OLV Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K011204.
XLTEK SLEEP SYSTEM
K022037 · Excel Tech. , Ltd. · Sep 2002
PSG INPUT BOX, MODEL JE-912AK
K022121 · Nihon Kohden America, Inc. · Jul 2002
SOMNO STAR & SERIES SLEEP SYSTEM
K012085 · Sensor Medics Corp. · Aug 2001
BIO-LOGIC SLEEPSCAN NETLINK
K003681 · Bio-Logic Systems Corp. · Dec 2000
VITAPORT 3
K000338 · Nihon Kohden America, Inc. · Apr 2000
NEUROFAX, MODEL EEG-1100A
K992742 · Nihon Kohden America, Inc. · Oct 1999