Cleared Traditional

K854049 - HEYER-SCHULTE SYRINGO PERITONEAL SHUNT

K854049 is the FDA 510(k) clearance for HEYER-SCHULTE SYRINGO PERITONEAL SHUNT by American V. Mueller. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K854049 · American V. Mueller · Neurology device
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Nov 1985
Decision
55d
Days
Class 2
Risk

K854049 is an FDA 510(k) clearance for the HEYER-SCHULTE SYRINGO PERITONEAL SHUNT. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by American V. Mueller (Chicago, US). The FDA issued a Cleared decision on November 27, 1985 after a review of 55 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 American V. Mueller devices

Submission Details

510(k) Number K854049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1985
Decision Date November 27, 1985
Days to Decision 55 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 148d · This submission: 55d
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 K854049.
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
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
K854474 · Cordis Corp. · Nov 1985
H-H ATRIAL CATHETERS & PERITONEAL CATHETERS
K853371 · Holter-Hausner Intl. · Sep 1985
ACCU-FLO PRESSURE VALVE
K853215 · Codman & Shurtleff, Inc. · Sep 1985