Cleared Traditional

K911410 - PS MEDICAL BUTTON VALVE (FDA 510(k) Clearance)

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

K911410 · Pudenz-Schulte Medical Research Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
88d
Days
Class 2
Risk

K911410 is an FDA 510(k) clearance for the PS MEDICAL BUTTON VALVE. 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 June 28, 1991 after a review of 88 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 K911410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date June 28, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
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 257
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K911410.
Intellidrop
K251598 · Brainspace, Inc. · Dec 2025
Sophy Mini Monopressure Valve (SM1)
K250636 · Sophysa · Nov 2025
EVAC-MRI
K252514 · Phasor Health, LLC · Nov 2025
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
K243531 · Integra Lifesciences Production Corporation · Aug 2025
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761)
K243552 · Integra Lifesciences Production Corporation · Aug 2025
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
K242974 · Sophysa · Jun 2025