Cleared Traditional

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 (K030297) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 98
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K030297.
DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE
K091762 · Covidien · Dec 2009
GE ENTROPY SENSOR
K082540 · Ge Healthcare · Nov 2008
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K062580 · Ge Healthcare · Dec 2007
TENZCARE ELECTRODE 6862
K893793 · 3M Company · Nov 1989
STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.
K881749 · Medtronic Vascular · Jul 1988
MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
K875284 · Medtronic Vascular · Jan 1988