Cleared Traditional

K864676 - HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM

K864676 is an FDA 510(k) clearance for HEYER-SCHULTE HERMETIC EXTERNAL CSF DRA..., manufactured by American V. Mueller. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K864676 · American V. Mueller · Neurology device
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Dec 1986
Decision
27d
Days
Class 2
Risk

K864676 is an FDA 510(k) clearance for the HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM. 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 December 29, 1986 after a review of 27 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

FDA 510(k) Submission Details - K864676

510(k) Number K864676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date December 29, 1986
Days to Decision 27 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
121d faster than avg
Panel avg: 148d · This submission: 27d
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 220
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K864676.
HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
K871685 · American V. Mueller · Jun 1987
CSF-CARDIAC/PERITONEAL CATHETER
K871752 · Pudenz-Schulte Medical Research Corp. · May 1987
H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
K870660 · Holter-Hausner Intl. · May 1987
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
K862907 · Pudenz-Schulte Medical Research Corp. · Dec 1986
CAMINO CSF DRAINAGE SYSTEM MODEL 040
K861961 · Camino Laboratories, Inc. · Aug 1986
BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.
K862303 · Pudenz-Schulte Medical Research Corp. · Aug 1986