Cleared Traditional

K924473 - DISPOSABLE THERAPY ELECTRODE

K924473 is an FDA 510(k) clearance for DISPOSABLE THERAPY ELECTRODE, manufactured by Zimmer Elektromedizin GmbH. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K924473 · Zimmer Elektromedizin GmbH · Neurology device
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May 1993
Decision
261d
Days
Class 2
Risk

K924473 is an FDA 510(k) clearance for the DISPOSABLE THERAPY ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Zimmer Elektromedizin GmbH (Irvine, US). The FDA issued a Cleared decision on May 19, 1993 after a review of 261 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K924473

510(k) Number K924473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date May 19, 1993
Days to Decision 261 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 149d · This submission: 261d
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 440
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K924473.
TPK CUTANEOUS ELECTRODE
K931925 · Staodyne, Inc. · Aug 1993
MONOTRODE CUTANEOUS ELECTRODE
K915864 · Henley Intl. · Jul 1993
EMITENS ELECTRODES
K922393 · Electronic Monitors, Inc. · Jul 1993
REUSABLE FINGER CLIP RECORDING ELECTRODE
K925706 · Chalgren Enterprises, Inc. · Feb 1993
ELECTROLINK
K920674 · Kold Products · Jan 1993
PRO-CHILL STIMPACK
K912210 · Tko, Inc. · Nov 1992
K924473 · DISPOSABLE THERAPY ELECTRODE
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