Cleared Traditional

K803257 - CSG-FLOW CONTROL VALVE

K803257 is an FDA 510(k) clearance for CSG-FLOW CONTROL VALVE, manufactured by Pudenz-Schulte Medical Research Corp.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K803257 · Pudenz-Schulte Medical Research Corp. · Neurology device
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Jan 1981
Decision
30d
Days
Class 2
Risk

K803257 is an FDA 510(k) clearance for the CSG-FLOW CONTROL VALVE. 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 January 22, 1981 after a review of 30 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.

FDA 510(k) Submission Details - K803257

510(k) Number K803257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1980
Decision Date January 22, 1981
Days to Decision 30 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
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

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 259
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K803257.
H-H BURR HOLE CATHETER SUPPORT
K820311 · Holter-Hausner Intl. · Feb 1982
EXTERNAL VENTRICULAR DRAINAGE SYS.
K820247 · American Heyer Schulte · Feb 1982
SPETZLER LUMBAR-PERITONEAL SYSTEM
K811288 · American Heyer Schulte · Jun 1981
AMERICAN HEYER-SCHULTE LOW PROFILE VALVE
K802586 · American Heyer Schulte · Dec 1980
H-H FIFTH VENTRICLE
K800168 · Holter-Hausner Intl. · Jan 1980
CSF-CARDIAC/PERITONEAL CATHETER
K792005 · Pudenz-Schulte Medical Research Corp. · Jan 1980
K803257 · CSG-FLOW CONTROL VALVE
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