Cleared Traditional

K000514 - RUMBAR DRAINAGE SYSTEM

K000514 is an FDA 510(k) clearance for RUMBAR DRAINAGE SYSTEM, manufactured by Phoenix Biomedical Corp.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K000514 · Phoenix Biomedical Corp. · Neurology device
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May 2000
Decision
84d
Days
Class 2
Risk

K000514 is an FDA 510(k) clearance for the RUMBAR DRAINAGE SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Phoenix Biomedical Corp. (Valley Forge, US). The FDA issued a Cleared decision on May 10, 2000 after a review of 84 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 Phoenix Biomedical Corp. devices

FDA 510(k) Submission Details - K000514

510(k) Number K000514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2000
Decision Date May 10, 2000
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 148d · This submission: 84d
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 207
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K000514.
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
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XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · Radionics, Inc. · Aug 2000
SIPHONGUARD CSF CONTROL DEVICE
K992173 · Johnson & Johnson Professionals, Inc. · Apr 2000
RADIONICS LUMBOPERITONEAL SHUNT
K000057 · Radionics, Inc. · Mar 2000
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
K990660 · Nmt Neurosciences Implants S.A. · Sep 1999