Cleared Traditional

K141227 - POLARIS PRESSURE ADJUSTABLE VALVE SYSTE...

K141227 is an FDA 510(k) clearance for POLARIS PRESSURE ADJUSTABLE VALVE SYSTE..., manufactured by Sophysa SA. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K141227 · Sophysa SA · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
325d
Days
Class 2
Risk

K141227 is an FDA 510(k) clearance for the POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Sophysa SA (Mission Viejo, US). The FDA issued a Cleared decision on April 2, 2015 after a review of 325 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Sophysa SA devices

FDA 510(k) Submission Details - K141227

510(k) Number K141227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2014
Decision Date April 02, 2015
Days to Decision 325 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 148d · This submission: 325d
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 181
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K141227.
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
K153041 · Integra LifeSciences Corporation · Mar 2016
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
K152897 · Integra LifeSciences Corporation · Mar 2016
Codman Certas Plus Programmable Valve
K152152 · Medos International SARL · Oct 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
K141687 · Aesculap, Inc. · Apr 2015
Codman Certas Plus Programmable Valve
K143111 · Medos International SARL · Feb 2015
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
K140722 · Integra LifeSciences Corporation · Jan 2015