Cleared Traditional

K891456 - HEYER-SCHULTE (CSF) VENTRI ACCESS(RESER...

K891456 is the FDA 510(k) clearance for HEYER-SCHULTE (CSF) VENTRI ACCESS(RESER... by Baxter Healthcare Corp. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K891456 · Baxter Healthcare Corp · Neurology device
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Jun 1989
Decision
100d
Days
Class 2
Risk

K891456 is an FDA 510(k) clearance for the HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM. 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 June 23, 1989 after a review of 100 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K891456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1989
Decision Date June 23, 1989
Days to Decision 100 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
48d faster than avg
Panel avg: 148d · This submission: 100d
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 159
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K891456.
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR
K896167 · Pudenz-Schulte Medical Research Corp. · Dec 1989
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
K892215 · Codman & Shurtleff, Inc. · Aug 1989
THE PUDENZ IN LINE VALVE
K894072 · Baxter Healthcare Corp · Aug 1989
H-H FLUSHING RESERVOIR
K875287 · Holter-Hausner Intl. · Jul 1988
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
K874508 · Holter-Hausner Intl. · Jan 1988
CSF-FLOW CONTROL VALVE, ULTRA SMALL
K873247 · Pudenz-Schulte Medical Research Corp. · Sep 1987