Cleared Traditional

K053058 - XLTEK NEUROPATH, MODEL PK1070

K053058 is an FDA 510(k) clearance for XLTEK NEUROPATH, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Neurology device with product code JXE cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K053058 · Excel Tech. , Ltd. · Neurology device
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Feb 2006
Decision
99d
Days
Class 2
Risk

K053058 is an FDA 510(k) clearance for the XLTEK NEUROPATH, MODEL PK1070. Classified as Device, Nerve Conduction Velocity Measurement (product code JXE), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on February 7, 2006 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1550 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Excel Tech. , Ltd. devices

FDA 510(k) Submission Details - K053058

510(k) Number K053058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2005
Decision Date February 07, 2006
Days to Decision 99 days
Submission Type Traditional
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
49d faster than avg
Panel avg: 148d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXE Device Classification - Class 2, Special Controls

Product Code JXE Device, Nerve Conduction Velocity Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1550
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 - JXE Device, Nerve Conduction Velocity Measurement

All 14
Devices cleared under the same product code (JXE) and FDA review panel - the closest regulatory comparables to K053058.
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MODIFICATION TO NC-STAT
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MODIFICATION OF NC-STAT
K013459 · Neurometrix, Inc. · Jan 2002