Cleared Traditional

CODMAN HAKIM MICRO PRECISION VALVE (K973774) - FDA 510(k) Clearance

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

K973774 · Johnson & Johnson Professionals, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
87d
Days
Class 2
Risk

K973774 is an FDA 510(k) clearance for the CODMAN HAKIM MICRO PRECISION VALVE. 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 December 29, 1997 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K973774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1997
Decision Date December 29, 1997
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
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 94
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K973774.
SIPHONGUARD CSF CONTROL DEVICE
K992173 · Johnson & Johnson Professionals, Inc. · Apr 2000
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778 · Johnson & Johnson Professionals, Inc. · Jul 1998
HAKIM PROGRAMMABLE VALVE SYSTEM
K974739 · Johnson & Johnson Professionals, Inc. · Jul 1998
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923 · Johnson & Johnson Professionals, Inc. · Jun 1997
CORDIS SHARP-ENDED STYLET
K955265 · Cordis Corp. · Dec 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159 · Cordis Corp. · Oct 1996