Cleared Traditional

PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) (K935560) - FDA 510(k) Clearance

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

K935560 · Pmt Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
355d
Days
Class 2
Risk

K935560 is an FDA 510(k) clearance for the PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS). Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on November 7, 1994 after a review of 355 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pmt Corp. devices

Submission Details

510(k) Number K935560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1993
Decision Date November 07, 1994
Days to Decision 355 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 148d · This submission: 355d
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 K935560.
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