Cleared Abbreviated

MPW HEMODIALYSIS WATER PURIFICATION SYSTEM (K001755) - FDA 510(k) Clearance

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

K001755 · Mpw Industrial Water Services, Inc. · Gastroenterology & Urology device
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Aug 2002
Decision
787d
Days
Class 2
Risk

K001755 is an FDA 510(k) clearance for the MPW HEMODIALYSIS WATER PURIFICATION SYSTEM. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Mpw Industrial Water Services, Inc. (Brunswick, US). The FDA issued a Cleared decision on August 5, 2002 after a review of 787 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: High-complexity regulatory submission. Standards-verified equivalence. 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 Mpw Industrial Water Services, Inc. devices

Submission Details

510(k) Number K001755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2000
Decision Date August 05, 2002
Days to Decision 787 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
657d slower than avg
Panel avg: 130d · This submission: 787d
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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