Cleared Traditional

K921319 - NEUROMED MODEL OCA-30 OCTODE AND MODEL ...

K921319 is the FDA 510(k) clearance for NEUROMED MODEL OCA-30 OCTODE AND MODEL ... by Neuromed, Inc.. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K921319 · Neuromed, Inc. · Neurology device
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May 1993
Decision
412d
Days
Class 2
Risk

K921319 is an FDA 510(k) clearance for the NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30. 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 May 5, 1993 after a review of 412 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 K921319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1992
Decision Date May 05, 1993
Days to Decision 412 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
264d slower than avg
Panel avg: 148d · This submission: 412d
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
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