Cleared Traditional

K021537 - MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005

K021537 is an FDA 510(k) clearance for MULTIPURPOSE NEUROPLUS ELECTRODE, manufactured by Vermont Medical, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K021537 · Vermont Medical, Inc. · Neurology device
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Mar 2003
Decision
297d
Days
Class 2
Risk

K021537 is an FDA 510(k) clearance for the MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Vermont Medical, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on March 3, 2003 after a review of 297 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.

FDA 510(k) Submission Details - K021537

510(k) Number K021537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date March 03, 2003
Days to Decision 297 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
148d slower than avg
Panel avg: 149d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

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 439
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K021537 · MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005
Download PDF Vermont Medical, Inc.