Cleared Traditional

K933801 - ELECTRODE

K933801 is an FDA 510(k) clearance for ELECTRODE, manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 443-day FDA review.

K933801 · Cadwell Laboratories, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
443d
Days
Class 2
Risk

K933801 is an FDA 510(k) clearance for the ELECTRODE, CUTANEOUS. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on October 21, 1994 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Cadwell Laboratories, Inc. devices

FDA 510(k) Submission Details - K933801

510(k) Number K933801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1993
Decision Date October 21, 1994
Days to Decision 443 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
295d slower than avg
Panel avg: 148d · This submission: 443d
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 210
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K933801.
CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS
K944603 · Conmedcorp · Dec 1994
SMARTBRACE ELECTRODE
K940012 · Medical Devices, Inc. · Dec 1994
ELECTROFLEX
K943126 · Medical Devices, Inc. · Dec 1994
DANTEC 13R45 BAR ELECTRODE
K934580 · Dantec Medical, Inc. · Sep 1994
CUTANEOUS ELECTRODE
K933802 · Cadwell Laboratories, Inc. · Sep 1994
GROUND PLATE ELECTRODE
K933807 · Cadwell Laboratories, Inc. · Jul 1994