Cleared Traditional

K896167 - PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR

K896167 is the FDA 510(k) clearance for PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR 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 57-day FDA review.

K896167 · Pudenz-Schulte Medical Research Corp. · Neurology device
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Dec 1989
Decision
57d
Days
Class 2
Risk

K896167 is an FDA 510(k) clearance for the PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Goleta, US). The FDA issued a Cleared decision on December 21, 1989 after a review of 57 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 Pudenz-Schulte Medical Research Corp. devices

Submission Details

510(k) Number K896167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1989
Decision Date December 21, 1989
Days to Decision 57 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
91d faster than avg
Panel avg: 148d · This submission: 57d
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 K896167.
PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
K902783 · Pudenz-Schulte Medical Research Corp. · Aug 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
K902257 · Codman & Shurtleff, Inc. · Jul 1990
CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT
K900676 · Pudenz-Schulte Medical Research Corp. · Apr 1990
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
K892215 · Codman & Shurtleff, Inc. · Aug 1989
THE PUDENZ IN LINE VALVE
K894072 · Baxter Healthcare Corp · Aug 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K891456 · Baxter Healthcare Corp · Jun 1989