Cleared Traditional

K140722 - INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS

K140722 is an FDA 510(k) clearance for INTEGRA FLOW REGULATING VALVE SYSTEMS O..., manufactured by Integra LifeSciences Corporation. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K140722 · Integra LifeSciences Corporation · Neurology device
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Jan 2015
Decision
291d
Days
Class 2
Risk

K140722 is an FDA 510(k) clearance for the INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATI.... Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Burlington, US). The FDA issued a Cleared decision on January 6, 2015 after a review of 291 days - an extended review 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: 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 Integra LifeSciences Corporation devices

FDA 510(k) Submission Details - K140722

510(k) Number K140722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2014
Decision Date January 06, 2015
Days to Decision 291 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
143d slower than avg
Panel avg: 148d · This submission: 291d
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 220
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K140722.
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
K141227 · Sophysa SA · Apr 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
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
K121248 · Moller Medical GmbH · Dec 2013
SHUNTCHECK
K123554 · Neurodx Development, LLC · Mar 2013
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K123524 · Medtronic Neurosurgery · Feb 2013