Cleared Traditional

K831396 - P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT

K831396 is the FDA 510(k) clearance for P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT by Pudenz-Schulte Medical Research Corp.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K831396 · Pudenz-Schulte Medical Research Corp. · Neurology device
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Aug 1983
Decision
105d
Days
Class 2
Risk

K831396 is an FDA 510(k) clearance for the P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 105 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 Pudenz-Schulte Medical Research Corp. devices

Submission Details

510(k) Number K831396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1983
Decision Date August 12, 1983
Days to Decision 105 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 148d · This submission: 105d
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 156
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K831396.
H-H CRUCIFORM-SLIT VALVE
K853363 · Holter-Hausner Intl. · Sep 1985
H-H VENTRICULAR CATHETERS & RESERVOIRS
K853361 · Holter-Hausner Intl. · Aug 1985
RADIONICS MINI & STANDARD SHUNT VALVE
K843132 · Radionics, Inc. · Sep 1984
P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
K831678 · Pudenz-Schulte Medical Research Corp. · Jun 1983
H-H IN-LINE VALVED CATHETER 2 TYPES
K830894 · Holter-Hausner Intl. · Apr 1983
P-S CSF-VENTRICULAR CATHETER, FLANGED
K823503 · Pudenz-Schulte Medical Research Corp. · Mar 1983