Cleared Traditional

K002969 - XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8

K002969 is an FDA 510(k) clearance for XLTEK EVOKED POTENTIAL HEADBOX, manufactured by Xltek. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K002969 · Xltek · Neurology device
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Dec 2000
Decision
77d
Days
Class 2
Risk

K002969 is an FDA 510(k) clearance for the XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Xltek (Oakville, CA). The FDA issued a Cleared decision on December 8, 2000 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Xltek devices

FDA 510(k) Submission Details - K002969

510(k) Number K002969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2000
Decision Date December 08, 2000
Days to Decision 77 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 148d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 93
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K002969.
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
K010092 · Excel Tech. , Ltd. · Apr 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
K010090 · Excel Tech. , Ltd. · Mar 2001
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
K010087 · Excel Tech. , Ltd. · Mar 2001
NEUROMAP WITH NEURO 100
K002773 · Radionics, Inc. · Oct 2000
DA VINCHI EEG AND EMG/EP SYSTEMS
K000963 · Airsep Corp. · Oct 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
K001101 · Excel Tech. , Ltd. · Jun 2000