Cleared Traditional

AIW WATER SYSTEM FOR HEMODIALYSIS (K001282) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001282 · American Industrial Water · Gastroenterology & Urology device
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Dec 2000
Decision
238d
Days
Class 2
Risk

K001282 is an FDA 510(k) clearance for the AIW WATER SYSTEM FOR HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by American Industrial Water (Wichita, US). The FDA issued a Cleared decision on December 15, 2000 after a review of 238 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 American Industrial Water devices

Submission Details

510(k) Number K001282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2000
Decision Date December 15, 2000
Days to Decision 238 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 130d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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