Cleared Traditional

NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC (K930536) - FDA 510(k) Clearance

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

K930536 · Neuromed, Inc. · Neurology device
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Dec 1994
Decision
687d
Days
Class 2
Risk

K930536 is an FDA 510(k) clearance for the NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC. 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 December 15, 1994 after a review of 687 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Neuromed, Inc. devices

Submission Details

510(k) Number K930536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1993
Decision Date December 15, 1994
Days to Decision 687 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
539d slower than avg
Panel avg: 148d · This submission: 687d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 138
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K930536.
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