Cleared Traditional

CODMAN-MEDOS VALVE SHUNT SYSTEM (K944222) - FDA 510(k) Clearance

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

K944222 · Johnson & Johnson Professionals, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
332d
Days
Class 2
Risk

K944222 is an FDA 510(k) clearance for the CODMAN-MEDOS VALVE SHUNT SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Randolph, US). The FDA issued a Cleared decision on July 28, 1995 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K944222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1994
Decision Date July 28, 1995
Days to Decision 332 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 148d · This submission: 332d
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 K944222.
CORDIS VENTRICULAR ANTECHAMBER (VA)
K955832 · Cordis Corp. · Mar 1996
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
K954021 · Johnson & Johnson Professionals, Inc. · Oct 1995
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
K944595 · Cordis Corp. · Oct 1995
CORDIS GRAVITY COMPENSATING ACCESSORY
K932429 · Cordis Corp. · Jul 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810 · Cordis Corp. · Mar 1994
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
K924600 · Cordis Corp. · Dec 1992