Cleared Traditional

K991519 - AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K991519 is an FDA 510(k) clearance for AMERIWATER PURIFICATION SYSTEM FOR HEMO..., manufactured by Ameriwater. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K991519 · Ameriwater · Gastroenterology & Urology device
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Apr 2000
Decision
350d
Days
Class 2
Risk

K991519 is an FDA 510(k) clearance for the AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Ameriwater (Dayton, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 350 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Ameriwater devices

FDA 510(k) Submission Details - K991519

510(k) Number K991519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1999
Decision Date April 14, 2000
Days to Decision 350 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 131d · This submission: 350d
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 82
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K991519.
DIALGUARD ENDOTOXIN REMOVAL DEVICE
K993806 · Clarigen, Inc. · Aug 2000
NELSON WATER SYSTEMS FOR HEMODIALYSIS
K993877 · Nelson Environmental Technologies, Inc. · May 2000
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K993520 · Serv-A-Pure Co. · May 2000
PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
K992786 · Pure Water, Inc. · Jan 2000
MD 420/440/460/470/480/490
K993200 · Isopure, Corp. · Jan 2000
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991916 · Virginia Water Systems, Inc. · Jan 2000