Cleared Traditional

K003957 - DIACLEAR ULTRAFILTER

K003957 is an FDA 510(k) clearance for DIACLEAR ULTRAFILTER, manufactured by Gambro Renal Products. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K003957 · Gambro Renal Products · Gastroenterology & Urology device
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Nov 2001
Decision
315d
Days
Class 2
Risk

K003957 is an FDA 510(k) clearance for the DIACLEAR ULTRAFILTER. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on November 1, 2001 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Gambro Renal Products devices

FDA 510(k) Submission Details - K003957

510(k) Number K003957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2000
Decision Date November 01, 2001
Days to Decision 315 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 131d · This submission: 315d
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 K003957.
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K041884 · Mueller Water Conditioning, Inc. · Feb 2005
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
K041163 · Isopure, Corp. · Oct 2004
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