Cleared Traditional

K811288 - SPETZLER LUMBAR-PERITONEAL SYSTEM

K811288 is an FDA 510(k) clearance for SPETZLER LUMBAR-PERITONEAL SYSTEM, manufactured by American Heyer Schulte. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K811288 · American Heyer Schulte · Neurology device
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Jun 1981
Decision
46d
Days
Class 2
Risk

K811288 is an FDA 510(k) clearance for the SPETZLER LUMBAR-PERITONEAL SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by American Heyer Schulte (Mchenry, US). The FDA issued a Cleared decision on June 26, 1981 after a review of 46 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 Heyer Schulte devices

FDA 510(k) Submission Details - K811288

510(k) Number K811288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1981
Decision Date June 26, 1981
Days to Decision 46 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 148d · This submission: 46d
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 226
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K811288.
P-S MED. LUMBO PERITONEAL & VENTRICULO-
K823509 · Pudenz-Schulte Medical Research Corp. · Dec 1982
H-H RICKHAM TYPE RESERVOIR
K820312 · Holter-Hausner Intl. · Mar 1982
H-H BURR HOLE CATHETER SUPPORT
K820311 · Holter-Hausner Intl. · Feb 1982
CSG-FLOW CONTROL VALVE
K803257 · Pudenz-Schulte Medical Research Corp. · Jan 1981
H-H FIFTH VENTRICLE
K800168 · Holter-Hausner Intl. · Jan 1980
CSF-CARDIAC/PERITONEAL CATHETER
K792005 · Pudenz-Schulte Medical Research Corp. · Jan 1980