Cleared Traditional

CONTOUR FLEX VALVES (REGULAR & SMALL) (K954285) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954285 · Radionics, Inc. · Neurology device
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Jan 1996
Decision
134d
Days
Class 2
Risk

K954285 is an FDA 510(k) clearance for the CONTOUR FLEX VALVES (REGULAR & SMALL). 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 January 26, 1996 after a review of 134 days - within the typical 510(k) review window.

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: 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 Radionics, Inc. devices

Submission Details

510(k) Number K954285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1995
Decision Date January 26, 1996
Days to Decision 134 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 148d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 78
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K954285.
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159 · Cordis Corp. · Oct 1996
VENTRICULAR CATHETER SET
K962097 · Cook, Inc. · Aug 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
K955832 · Cordis Corp. · Mar 1996
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
K954021 · Johnson & Johnson Professionals, Inc. · Oct 1995
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
K944595 · Cordis Corp. · Oct 1995
CODMAN-MEDOS VALVE SHUNT SYSTEM
K944222 · Johnson & Johnson Professionals, Inc. · Jul 1995