Cleared Traditional

K984583 - THE BIOPLATE SHUNT CONNECTOR

K984583 is an FDA 510(k) clearance for THE BIOPLATE SHUNT CONNECTOR, manufactured by Biomedics. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K984583 · Biomedics · Neurology device
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Mar 1999
Decision
81d
Days
Class 2
Risk

K984583 is an FDA 510(k) clearance for the THE BIOPLATE SHUNT CONNECTOR. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Biomedics (Los Angeles, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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 Biomedics devices

FDA 510(k) Submission Details - K984583

510(k) Number K984583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1998
Decision Date March 15, 1999
Days to Decision 81 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 148d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - JXG Shunt, Central Nervous System And Components

All 206
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K984583.
DIAMOND II VALVE
K991429 · Phoenix Biomedical Corp. · May 1999
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
K980903 · Radionics, Inc. · Apr 1999
CRX WORLD SHUNT
K990256 · Phoenix Biomedical Corp. · Apr 1999
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
K984053 · Medtronic PS Medical · Feb 1999
CRX DIAMOND VALVE
K974096 · Phoenix Biomedical Corp. · Dec 1998
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778 · Johnson & Johnson Professionals, Inc. · Jul 1998