Cleared Traditional

K221840 - Hakim Programmable Valves

K221840 is an FDA 510(k) clearance for Hakim Programmable Valves, manufactured by Integra Lifesciences Production Corporation. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K221840 · Integra Lifesciences Production Corporation · Neurology device
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Oct 2022
Decision
112d
Days
Class 2
Risk

K221840 is an FDA 510(k) clearance for the Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Lifesciences Production Corporation (Mansfield, US). The FDA issued a Cleared decision on October 14, 2022 after a review of 112 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 Integra Lifesciences Production Corporation devices

FDA 510(k) Submission Details - K221840

510(k) Number K221840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2022
Decision Date October 14, 2022
Days to Decision 112 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
36d faster than avg
Panel avg: 148d · This submission: 112d
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 177
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K221840.
Certas Plus Programmable Valves
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ReFlow System Mini
K221918 · Anuncia Medical, Inc. · Sep 2022
StrataMR II Valves and Shunts
K212641 · Medtronic Neurosurgery · Sep 2021
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K200950 · Aesculap, Inc. · May 2020