Cleared Abbreviated

K994279 - PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)

K994279 is an FDA 510(k) clearance for PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION), manufactured by Pure Water Solutions, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Abbreviated 510(k) pathway after a 368-day FDA review.

K994279 · Pure Water Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
368d
Days
Class 2
Risk

K994279 is an FDA 510(k) clearance for the PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION). Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Pure Water Solutions, Inc. (Englewood, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 368 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Pure Water Solutions, Inc. devices

FDA 510(k) Submission Details - K994279

510(k) Number K994279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1999
Decision Date December 22, 2000
Days to Decision 368 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
238d slower than avg
Panel avg: 130d · This submission: 368d
Pathway characteristics
Standards-based clearance path.

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 26
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K994279.
DIASAFEplusUS
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NX STAGE WATER PURIFICATION SYSTEM
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K983126 · Minntech Corp. · Mar 1999
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
K954349 · Minntech Corp. · Dec 1995
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · Fresenius USA, Inc. · Nov 1995