Cleared Traditional

K881616 - PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1

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

K881616 · Progress Mankind Technology · Neurology device
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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

FDA 510(k) Submission Details - K881616

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
Combination Product No
PCCP Authorized No
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.

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 192
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K881616.
THE PUDENZ IN LINE VALVE
K894072 · Baxter Healthcare Corp · Aug 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K891456 · Baxter Healthcare Corp · Jun 1989
PMT MODEL 1110-5 PMT PERITONEAL CATHETER
K884036 · Pmt Corp. · Dec 1988
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
K883114 · Pmt Corp. · Aug 1988
H-H FLUSHING RESERVOIR
K875287 · Holter-Hausner Intl. · Jul 1988
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
K874508 · Holter-Hausner Intl. · Jan 1988