Cleared Traditional

K030297 - FLEXIBLE RUBBER ELECTRODES

K030297 is an FDA 510(k) clearance for FLEXIBLE RUBBER ELECTRODES, manufactured by Enraf-Nonius, B.V.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030297 · Enraf-Nonius, B.V. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
90d
Days
Class 2
Risk

K030297 is an FDA 510(k) clearance for the FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 34441.... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Enraf-Nonius, B.V. (Delft, NL). The FDA issued a Cleared decision on April 28, 2003 after a review of 90 days - within the typical 510(k) review window.

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 Enraf-Nonius, B.V. devices

FDA 510(k) Submission Details - K030297

510(k) Number K030297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2003
Decision Date April 28, 2003
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 185
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K030297.
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COM-PATCH
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