Cleared Traditional

K852920 - QUADRA CATH ELECT(3MM SIZES) 1990J

K852920 is the FDA 510(k) clearance for QUADRA CATH ELECT(3MM SIZES) 1990J by Neuromed, Inc.. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K852920 · Neuromed, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
92d
Days
Class 2
Risk

K852920 is an FDA 510(k) clearance for the QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF. 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 October 10, 1985 after a review of 92 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K852920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1985
Decision Date October 10, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 148d · This submission: 92d
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 K852920.
MODEL 3487A PISCES EPIDURAL LEAD
K881491 · Medtronic Vascular · May 1988
MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
K873675 · Medtronic Vascular · Oct 1987
MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT
K855107 · Medtronic Vascular · May 1986
CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A
K852827 · Cordis Corp. · Aug 1985
MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL
K844115 · Medtronic Vascular · Feb 1985
MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL
K841584 · Medtronic Vascular · May 1984