Cleared Traditional

K932320 - NEUTRALIZER

K932320 is an FDA 510(k) clearance for NEUTRALIZER, manufactured by Smith and Nephew Donjoy, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K932320 · Smith and Nephew Donjoy, Inc. · Neurology device
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Oct 1993
Decision
148d
Days
Class 2
Risk

K932320 is an FDA 510(k) clearance for the NEUTRALIZER. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Smith and Nephew Donjoy, Inc. (Carsbad, US). The FDA issued a Cleared decision on October 6, 1993 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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 Smith and Nephew Donjoy, Inc. devices

FDA 510(k) Submission Details - K932320

510(k) Number K932320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1993
Decision Date October 06, 1993
Days to Decision 148 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
At panel average
Panel avg: 148d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 151
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