Cleared Special

K013813 - MODIFICATION TO:APEX MEDICAL IF-4100

K013813 is the FDA 510(k) clearance for MODIFICATION TO:APEX MEDICAL IF-4100 by Apex Medical Corp.. It is a Class 2 Neurology device (product code GXY) cleared through the Special 510(k) pathway after a 28-day FDA review.

K013813 · Apex Medical Corp. · Neurology device
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Dec 2001
Decision
28d
Days
Class 2
Risk

K013813 is an FDA 510(k) clearance for the MODIFICATION TO:APEX MEDICAL IF-4100. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on December 14, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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.

View all Apex Medical Corp. devices

Submission Details

510(k) Number K013813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2001
Decision Date December 14, 2001
Days to Decision 28 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
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 152
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