Cleared Traditional

K992742 - NEUROFAX, MODEL EEG-1100A

K992742 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 Traditional 510(k) pathway after a 59-day FDA review.

K992742 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
59d
Days
Class 2
Risk

K992742 is an FDA 510(k) clearance for the NEUROFAX, MODEL EEG-1100A. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on October 14, 1999 after a review of 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K992742

510(k) Number K992742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1999
Decision Date October 14, 1999
Days to Decision 59 days
Submission Type Traditional
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
90d faster than avg
Panel avg: 149d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 59
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K992742.
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K001013 · Airsep Corp. · May 2000
VITAPORT 3
K000338 · Nihon Kohden America, Inc. · Apr 2000
GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
K994142 · Grass Instrument Co. · Mar 2000
ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K992283 · Airsep Corp. · Aug 1999
H20- TETHERED OPTION
K992291 · Grass-Telefactor Product Group · Aug 1999
BIOSACA SYSTEM, MODEL 800
K991446 · Biosys AB (Publ) · Jul 1999