Cleared Traditional

K010092 - XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)

K010092 is an FDA 510(k) clearance for XLTEK EVOKED POTENTIAL HEADBOX, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K010092 · Excel Tech. , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
81d
Days
Class 2
Risk

K010092 is an FDA 510(k) clearance for the XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED). 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 April 2, 2001 after a review of 81 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.

FDA 510(k) Submission Details - K010092

510(k) Number K010092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2001
Decision Date April 02, 2001
Days to Decision 81 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
68d faster than avg
Panel avg: 149d · This submission: 81d
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 140
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K010092.
HIGH SPEED EMG MODULE
K031930 · Medical Measurement Systems B.V. · Mar 2004
EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
K032741 · Axon Systems, Inc. · Dec 2003
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
K020400 · Meps, LLC · Aug 2002
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
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
K002969 · Xltek · Dec 2000
K010092 · XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
Download PDF FDA Summary Excel Tech. , Ltd.