Cleared Traditional

THE PUDENZ IN LINE VALVE (K894072) - FDA 510(k) Clearance

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

K894072 · Baxter Healthcare Corp · Neurology device
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Aug 1989
Decision
60d
Days
Class 2
Risk

K894072 is an FDA 510(k) clearance for the THE PUDENZ IN LINE VALVE. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on August 7, 1989 after a review of 60 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K894072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1989
Decision Date August 07, 1989
Days to Decision 60 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
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 73
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K894072.
OPTYX
K904883 · Baxter Healthcare Corp · Jul 1991
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
K910853 · Cordis Corp. · Apr 1991
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K903844 · Cordis Corp. · Dec 1990
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K891456 · Baxter Healthcare Corp · Jun 1989
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
K862513 · Cordis Corp. · Aug 1986
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
K861377 · Cordis Corp. · Jun 1986