Cleared Traditional

K974739 - HAKIM PROGRAMMABLE VALVE SYSTEM

K974739 is an FDA 510(k) clearance for HAKIM PROGRAMMABLE VALVE SYSTEM, manufactured by Johnson & Johnson Professionals, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K974739 · Johnson & Johnson Professionals, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
194d
Days
Class 2
Risk

K974739 is an FDA 510(k) clearance for the HAKIM PROGRAMMABLE VALVE SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on July 1, 1998 after a review of 194 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 Johnson & Johnson Professionals, Inc. devices

FDA 510(k) Submission Details - K974739

510(k) Number K974739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1997
Decision Date July 01, 1998
Days to Decision 194 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
46d slower than avg
Panel avg: 148d · This submission: 194d
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 225
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K974739.
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
K984053 · Medtronic PS Medical · Feb 1999
CRX DIAMOND VALVE
K974096 · Phoenix Biomedical Corp. · Dec 1998
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778 · Johnson & Johnson Professionals, Inc. · Jul 1998
MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118
K981046 · Medtronic PS Medical · Jun 1998
SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
K974726 · Elekta Implants, SA · Mar 1998
GEMINI STANDARD AND MINI VALVES
K974708 · Neurocare Group · Mar 1998