Cleared Traditional

K926326 - MICROCARE(TM)

K926326 is an FDA 510(k) clearance for MICROCARE(TM), manufactured by American Imex. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K926326 · American Imex · Neurology device
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Jun 1993
Decision
169d
Days
Class 2
Risk

K926326 is an FDA 510(k) clearance for the MICROCARE(TM). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by American Imex (Irvine, US). The FDA issued a Cleared decision on June 1, 1993 after a review of 169 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K926326

510(k) Number K926326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date June 01, 1993
Days to Decision 169 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
20d slower than avg
Panel avg: 149d · This submission: 169d
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 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K926326.
NEUTRALIZER
K932320 · Smith and Nephew Donjoy, Inc. · Oct 1993
COM-TENS (SINGLE MODE)
K931570 · Ems Dist. · Jun 1993
MAXIMA I
K931424 · Staodyne, Inc. · Jun 1993
INTEGRITY 2
K923970 · Medrotech Corp. · May 1993
K-STIM CLEAR
K922202 · Katecho, Inc. · May 1993
STAODYN MAXIMA III
K930865 · Staodyne, Inc. · May 1993
K926326 · MICROCARE(TM)
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