Cleared Traditional

K970426 - VALUETRODE (FDA 510(k) Clearance)

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

K970426 · Axelgaard Mfg. Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
94d
Days
Class 2
Risk

K970426 is an FDA 510(k) clearance for the VALUETRODE. 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 May 9, 1997 after a review of 94 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 Axelgaard Mfg. Co., Ltd. devices

Submission Details

510(k) Number K970426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1997
Decision Date May 09, 1997
Days to Decision 94 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 148d · This submission: 94d
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 435
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K970426.
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
K253237 · Elde Medikal Sanayi ve Ticaret Anonim Sirketi · May 2026
MR Conditional Cup Electrodes
K254183 · Technomed Europe · May 2026
Tutamen Self Adhesive Electrodes
K252439 · Dongguan Tutamen Metalwork Co., Ltd. · May 2026
myosmart. (13E522)
K253256 · Otto Bock Healthcare Products GmbH · Apr 2026
Ceribell Brain Monitor Headband
K260363 · Ceribell, Inc. · Apr 2026
Remote Wave Electrode (AE03-50)
K260453 · Bionit Labs Srl · Mar 2026