Cleared Traditional

K011005 - PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS

K011005 is an FDA 510(k) clearance for PURE WATER SOLUTIONS CENTRAL WATER SYST..., manufactured by Pure Water Solutions, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 576-day FDA review.

K011005 · Pure Water Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
576d
Days
Class 2
Risk

K011005 is an FDA 510(k) clearance for the PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Pure Water Solutions, Inc. (Jackson, US). The FDA issued a Cleared decision on November 1, 2002 after a review of 576 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Pure Water Solutions, Inc. devices

FDA 510(k) Submission Details - K011005

510(k) Number K011005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2001
Decision Date November 01, 2002
Days to Decision 576 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
445d slower than avg
Panel avg: 131d · This submission: 576d
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 83
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K011005.
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
DIACLEAR ULTRAFILTER
K003957 · Gambro Renal Products · Nov 2001
WATER PURIFICATION SYSTEM
K994292 · Water & Power Technologies, Inc. · Jan 2001
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K994279 · Pure Water Solutions, Inc. · Dec 2000