Cleared Special

K052112 - XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059

K052112 is an FDA 510(k) clearance for XLTEK XCALIBUR EMG / LT, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Neurology device with product code IKN cleared through the Special 510(k) pathway after a 85-day FDA review.

K052112 · Excel Tech. , Ltd. · Neurology device
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Oct 2005
Decision
85d
Days
Class 2
Risk

K052112 is an FDA 510(k) clearance for the XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on October 28, 2005 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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 - K052112

510(k) Number K052112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2005
Decision Date October 28, 2005
Days to Decision 85 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
64d faster than avg
Panel avg: 149d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 74
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K052112.
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K052112 · XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
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