Cleared Traditional

K002045 - WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K002045 is an FDA 510(k) clearance for WATER PURIFICATION SYSTEM FOR HEMODIALYSIS, manufactured by Total Water Treatment Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K002045 · Total Water Treatment Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
226d
Days
Class 2
Risk

K002045 is an FDA 510(k) clearance for the WATER PURIFICATION SYSTEM FOR HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Total Water Treatment Systems, Inc. (Madison, US). The FDA issued a Cleared decision on February 16, 2001 after a review of 226 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 Total Water Treatment Systems, Inc. devices

FDA 510(k) Submission Details - K002045

510(k) Number K002045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2000
Decision Date February 16, 2001
Days to Decision 226 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
95d slower than avg
Panel avg: 131d · This submission: 226d
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 99
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K002045.
DIACLEAR ULTRAFILTER
K003957 · Gambro Renal Products · Nov 2001
AQUA WATER TREATMENT FOR HEMODIALYSIS
K010592 · Aqua Water Treatment, Inc. · Sep 2001
MAR COR SERVICES SEMPER PURE RO MACHINE
K003877 · Mar Cor Services, Inc. · Jun 2001
WATER PURIFICATION SYSTEM
K994292 · Water & Power Technologies, Inc. · Jan 2001
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K994279 · Pure Water Solutions, Inc. · Dec 2000
AIW WATER SYSTEM FOR HEMODIALYSIS
K001282 · American Industrial Water · Dec 2000