Cleared Traditional

K993806 - DIALGUARD ENDOTOXIN REMOVAL DEVICE

K993806 is an FDA 510(k) clearance for DIALGUARD ENDOTOXIN REMOVAL DEVICE, manufactured by Clarigen, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K993806 · Clarigen, Inc. · Gastroenterology & Urology device
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Aug 2000
Decision
279d
Days
Class 2
Risk

K993806 is an FDA 510(k) clearance for the DIALGUARD ENDOTOXIN REMOVAL DEVICE. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Clarigen, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 14, 2000 after a review of 279 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clarigen, Inc. devices

FDA 510(k) Submission Details - K993806

510(k) Number K993806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1999
Decision Date August 14, 2000
Days to Decision 279 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 131d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIP Device Classification - Class 2, Special Controls

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIP Subsystem, Water Purification

All 82
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K993806.
WATER PURIFICATION SYSTEM
K994292 · Water & Power Technologies, Inc. · Jan 2001
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K994279 · Pure Water Solutions, Inc. · Dec 2000
FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS
K991495 · Fluid Process Systems, Inc. · Aug 2000
NELSON WATER SYSTEMS FOR HEMODIALYSIS
K993877 · Nelson Environmental Technologies, Inc. · May 2000
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K993520 · Serv-A-Pure Co. · May 2000
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991519 · Ameriwater · Apr 2000