Cleared Traditional

K852326 - UNISTIM UNT-1

K852326 is an FDA 510(k) clearance for UNISTIM UNT-1, manufactured by Neuromed, Inc.. The device is a Class 2 Neurology device with product code GZB cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K852326 · Neuromed, Inc. · Neurology device
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Nov 1985
Decision
168d
Days
Class 2
Risk

K852326 is an FDA 510(k) clearance for the UNISTIM UNT-1. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Neuromed, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on November 14, 1985 after a review of 168 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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 Neuromed, Inc. devices

FDA 510(k) Submission Details - K852326

510(k) Number K852326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1985
Decision Date November 14, 1985
Days to Decision 168 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 148d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZB Device Classification - Class 2, Special Controls

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 118
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K852326.
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