Cleared Traditional

RING ELECTRODE (K933805) - FDA 510(k) Clearance

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

K933805 · Cadwell Laboratories, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 1994
Decision
502d
Days
Class 2
Risk

K933805 is an FDA 510(k) clearance for the RING ELECTRODE. 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 December 19, 1994 after a review of 502 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

Submission Details

510(k) Number K933805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1993
Decision Date December 19, 1994
Days to Decision 502 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
354d slower than avg
Panel avg: 148d · This submission: 502d
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 106
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K933805.
GE ENTROPY SENSOR
K082540 · Ge Healthcare · Nov 2008
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K062580 · Ge Healthcare · Dec 2007
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
K041953 · Conmedcorp · Aug 2004
CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS
K944603 · Conmedcorp · Dec 1994
CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE
K936101 · Conmedcorp · Jun 1994
CONMED VERSA-STIM INTERFERENTIAL ELECTRODE
K940704 · Conmedcorp · Jun 1994