Cleared Traditional

K010592 - AQUA WATER TREATMENT FOR HEMODIALYSIS

K010592 is an FDA 510(k) clearance for AQUA WATER TREATMENT FOR HEMODIALYSIS, manufactured by Aqua Water Treatment, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K010592 · Aqua Water Treatment, Inc. · Gastroenterology & Urology device
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Sep 2001
Decision
212d
Days
Class 2
Risk

K010592 is an FDA 510(k) clearance for the AQUA WATER TREATMENT FOR HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Aqua Water Treatment, Inc. (Navarre, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 212 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 Aqua Water Treatment, Inc. devices

FDA 510(k) Submission Details - K010592

510(k) Number K010592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2001
Decision Date September 28, 2001
Days to Decision 212 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 131d · This submission: 212d
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 99
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K010592.
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
K013677 · Usfilter/Ionpure, Inc. · Mar 2002
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K014169 · Bob J. Johnson & Assoc., Inc. · Feb 2002
DIACLEAR ULTRAFILTER
K003957 · Gambro Renal Products · Nov 2001
MAR COR SERVICES SEMPER PURE RO MACHINE
K003877 · Mar Cor Services, Inc. · Jun 2001
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K002045 · Total Water Treatment Systems, Inc. · Feb 2001
WATER PURIFICATION SYSTEM
K994292 · Water & Power Technologies, Inc. · Jan 2001