Cleared Special

K991429 - DIAMOND II VALVE

K991429 is an FDA 510(k) clearance for DIAMOND II VALVE, manufactured by Phoenix Biomedical Corp.. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 23-day FDA review.

K991429 · Phoenix Biomedical Corp. · Neurology device
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May 1999
Decision
23d
Days
Class 2
Risk

K991429 is an FDA 510(k) clearance for the DIAMOND II VALVE. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Phoenix Biomedical Corp. (Norristown, US). The FDA issued a Cleared decision on May 19, 1999 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K991429

510(k) Number K991429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date May 19, 1999
Days to Decision 23 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 149d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K991429.
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
K990660 · Nmt Neurosciences Implants S.A. · Sep 1999
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K992379 · Radionics, Inc. · Sep 1999
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
K981246 · Integra Neurocare, LLC · May 1999
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
K980903 · Radionics, Inc. · Apr 1999
CRX WORLD SHUNT
K990256 · Phoenix Biomedical Corp. · Apr 1999
THE BIOPLATE SHUNT CONNECTOR
K984583 · Biomedics · Mar 1999
K991429 · DIAMOND II VALVE
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