Cleared Traditional

K881616 - PMT MANKIND LUMBAR-PERITONEAL SHUNT MOD...

K881616 is the FDA 510(k) clearance for PMT MANKIND LUMBAR-PERITONEAL SHUNT MOD... by Progress Mankind Technology. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K881616 · Progress Mankind Technology · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
150d
Days
Class 2
Risk

K881616 is an FDA 510(k) clearance for the PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Progress Mankind Technology (Chanhassen, US). The FDA issued a Cleared decision on September 9, 1988 after a review of 150 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Progress Mankind Technology devices

Submission Details

510(k) Number K881616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1988
Decision Date September 09, 1988
Days to Decision 150 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 148d · This submission: 150d
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 99
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K881616.
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
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
K862513 · Cordis Corp. · Aug 1986
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
K861377 · Cordis Corp. · Jun 1986
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
K855058 · Cordis Corp. · Jan 1986