Cleared Traditional

K935560 - PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS)

K935560 is an FDA 510(k) clearance for PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS), manufactured by Pmt Corp.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 355-day FDA review.

K935560 · Pmt Corp. · Neurology device
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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

FDA 510(k) Submission Details - K935560

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
Combination Product No
PCCP Authorized No
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.

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 216
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K935560.
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
K951258 · Pudenz-Schulte Medical Research Corp. · Sep 1995
CODMAN-MEDOS VALVE SHUNT SYSTEM
K944222 · Johnson & Johnson Professionals, Inc. · Jul 1995
CAMINO VENTRICULAR DRAINAGE SYSTEM
K932769 · Camino Laboratories, Inc. · Mar 1995
CORDIS GRAVITY COMPENSATING ACCESSORY
K932429 · Cordis Corp. · Jul 1994
PS MEDICAL DELTA BURR HOLE VALVE
K934545 · Pudenz-Schulte Medical Research Corp. · Apr 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810 · Cordis Corp. · Mar 1994