Cleared Traditional

K083756 - GUARDIAN 150 ELECTRODE

K083756 is the FDA 510(k) clearance for GUARDIAN 150 ELECTRODE by Selectivemed Components, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K083756 · Selectivemed Components, Inc. · Neurology device
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Jun 2009
Decision
191d
Days
Class 2
Risk

K083756 is an FDA 510(k) clearance for the GUARDIAN 150 ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Selectivemed Components, Inc. (Roswell, US). The FDA issued a Cleared decision on June 26, 2009 after a review of 191 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 Selectivemed Components, Inc. devices

Submission Details

510(k) Number K083756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2008
Decision Date June 26, 2009
Days to Decision 191 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
43d slower than avg
Panel avg: 148d · This submission: 191d
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 118
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