Cleared Traditional

K182265 - CodMan Certas Plus Programmable Valve (FDA 510(k) Clearance)

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

K182265 · Integra Lifesciences Corp. · Neurology device
Nov 2018
Decision
91d
Days
Class 2
Risk

K182265 is an FDA 510(k) clearance for the CodMan Certas Plus Programmable Valve. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Mansfield, US). The FDA issued a Cleared decision on November 20, 2018 after a review of 91 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.

Submission Details

510(k) Number K182265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2018
Decision Date November 20, 2018
Days to Decision 91 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 162d · This submission: 91d
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 10
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K182265.
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