Cleared Traditional

K905596 - NEUROMED OCTRODE MODEL MNR-88B/88C NEUR...

K905596 is the FDA 510(k) clearance for NEUROMED OCTRODE MODEL MNR-88B/88C NEUR... by Neuromed, Inc.. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K905596 · Neuromed, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
88d
Days
Class 2
Risk

K905596 is an FDA 510(k) clearance for the NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST. 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 March 11, 1991 after a review of 88 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 K905596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1990
Decision Date March 11, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
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 K905596.
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
K912764 · Medtronic Vascular · Nov 1991
MEDTRONIC 3625 SCREENER SYSTEM
K913442 · Medtronic Vascular · Nov 1991
ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
K905569 · Biomedical Life Systems, Inc. · Jun 1991
MEDTRONIC (R) MODEL 3625 SCREENER
K903690 · Medtronic Vascular · Feb 1991
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K910199 · Medtronic Vascular · Feb 1991
MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME
K905407 · Medtronic Vascular · Feb 1991