Cleared Abbreviated

PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) (K994279) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K994279 · Pure Water Solutions, Inc. · Gastroenterology & Urology device
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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

Submission Details

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.

Device Classification

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.

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