Cleared Traditional

K905255 - NEUROMED MODEL 1992 LS LAMITRODE LEAD

K905255 is the FDA 510(k) clearance for NEUROMED MODEL 1992 LS LAMITRODE LEAD by Neuromed, Inc.. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K905255 · Neuromed, Inc. · Neurology device
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Jan 1991
Decision
65d
Days
Class 2
Risk

K905255 is an FDA 510(k) clearance for the NEUROMED MODEL 1992 LS LAMITRODE LEAD. 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 January 25, 1991 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neuromed, Inc. devices

Submission Details

510(k) Number K905255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1990
Decision Date January 25, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 148d · This submission: 65d
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 76
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K905255.
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MODEL 3586 RESUME LEAD
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