Cleared Special

K042223 - XLTEK CONNEX IP HEADBOX, MODEL 1054

K042223 is an FDA 510(k) clearance for XLTEK CONNEX IP HEADBOX, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Neurology device with product code OMB cleared through the Special 510(k) pathway after a 30-day FDA review.

K042223 · Excel Tech. , Ltd. · Neurology device
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Sep 2004
Decision
30d
Days
Class 2
Risk

K042223 is an FDA 510(k) clearance for the XLTEK CONNEX IP HEADBOX, MODEL 1054. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on September 16, 2004 after a review of 30 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.

FDA 510(k) Submission Details - K042223

510(k) Number K042223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2004
Decision Date September 16, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

OMB Device Classification - Class 2, Special Controls

Product Code OMB Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User
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 - OMB Automatic Event Detection Software For Full-montage Electroencephalograph

All 41
Devices cleared under the same product code (OMB) and FDA review panel - the closest regulatory comparables to K042223.
ICTA
K120260 · Excel-Tech Ltd. (Xltek) · Jun 2012
NATUS NEUROWORKS, MODEL 104196
K090019 · Natus Medical, Inc. · Feb 2010
IDENTEVENT, VERSION 1.0G
K092039 · Optima Neuroscience, Inc. · Oct 2009
PERSYST REVEAL
K011397 · Persyst Development Corp. · Aug 2001
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
K010085 · Excel Tech. , Ltd. · Mar 2001
EEG SPIKE AND EVENT DETECTOR MODULE
K002332 · Excel Tech. , Ltd. · Oct 2000
K042223 · XLTEK CONNEX IP HEADBOX, MODEL 1054
Download PDF Excel Tech. , Ltd.