Cleared Traditional

K980903 - RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT

K980903 is an FDA 510(k) clearance for RADIONICS EQUI-FLOW VALVE, manufactured by Radionics, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 405-day FDA review.

K980903 · Radionics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
405d
Days
Class 2
Risk

K980903 is an FDA 510(k) clearance for the RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on April 19, 1999 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Radionics, Inc. devices

FDA 510(k) Submission Details - K980903

510(k) Number K980903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1998
Decision Date April 19, 1999
Days to Decision 405 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 148d · This submission: 405d
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 224
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K980903.
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K992379 · Radionics, Inc. · Sep 1999
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
K981246 · Integra Neurocare, LLC · May 1999
DIAMOND II VALVE
K991429 · Phoenix Biomedical Corp. · May 1999
CRX WORLD SHUNT
K990256 · Phoenix Biomedical Corp. · Apr 1999
THE BIOPLATE SHUNT CONNECTOR
K984583 · Biomedics · Mar 1999
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
K984053 · Medtronic PS Medical · Feb 1999