Cleared Traditional

K132422 - PALS PLATINUM NEUROSTIMULATION ELECTRODES

K132422 is the FDA 510(k) clearance for PALS PLATINUM NEUROSTIMULATION ELECTRODES by Axelgaard Mfg. Co., Ltd.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K132422 · Axelgaard Mfg. Co., Ltd. · Neurology device
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Feb 2014
Decision
192d
Days
Class 2
Risk

K132422 is an FDA 510(k) clearance for the PALS PLATINUM NEUROSTIMULATION ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Axelgaard Mfg. Co., Ltd. (Fallbrook, US). The FDA issued a Cleared decision on February 13, 2014 after a review of 192 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Axelgaard Mfg. Co., Ltd. devices

Submission Details

510(k) Number K132422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2013
Decision Date February 13, 2014
Days to Decision 192 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 148d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 147
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