Cleared Traditional

K884036 - PMT MODEL 1110-5 PMT PERITONEAL CATHETER

K884036 is the FDA 510(k) clearance for PMT MODEL 1110-5 PMT PERITONEAL CATHETER by Pmt Corp.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K884036 · Pmt Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
87d
Days
Class 2
Risk

K884036 is an FDA 510(k) clearance for the PMT MODEL 1110-5 PMT PERITONEAL CATHETER. 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 December 22, 1988 after a review of 87 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 Pmt Corp. devices

Submission Details

510(k) Number K884036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1988
Decision Date December 22, 1988
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
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 157
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K884036.
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
K892215 · Codman & Shurtleff, Inc. · Aug 1989
THE PUDENZ IN LINE VALVE
K894072 · Baxter Healthcare Corp · Aug 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K891456 · Baxter Healthcare Corp · Jun 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