Cleared Traditional

K001101 - XLTEK EVOKED POTENTIAL HEADBOX

K001101 is the FDA 510(k) clearance for XLTEK EVOKED POTENTIAL HEADBOX by Excel Tech. , Ltd.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K001101 · Excel Tech. , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
86d
Days
Class 2
Risk

K001101 is an FDA 510(k) clearance for the XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on June 30, 2000 after a review of 86 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 Excel Tech. , Ltd. devices

Submission Details

510(k) Number K001101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2000
Decision Date June 30, 2000
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 50
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K001101.
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
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
K991899 · Nihon Kohden America, Inc. · Sep 1999
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
K992313 · Excel Tech. , Ltd. · Aug 1999
GALILEO EVOKED POTENTIALRE
K963662 · Biosound, Inc. · Feb 1997