Cleared Traditional

K092481 - HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2

K092481 is an FDA 510(k) clearance for HEMODIALYSIS CARBON EXCHANGE, manufactured by New Aqua, LLC (Dba Aqua Systems). The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K092481 · New Aqua, LLC (Dba Aqua Systems) · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
232d
Days
Class 2
Risk

K092481 is an FDA 510(k) clearance for the HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZE.... Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by New Aqua, LLC (Dba Aqua Systems) (Avon, US). The FDA issued a Cleared decision on April 2, 2010 after a review of 232 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 New Aqua, LLC (Dba Aqua Systems) devices

FDA 510(k) Submission Details - K092481

510(k) Number K092481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2009
Decision Date April 02, 2010
Days to Decision 232 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
101d slower than avg
Panel avg: 131d · This submission: 232d
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 K092481.
MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K110578 · Mar Cor Purification, Inc. · May 2011
ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
K102892 · Aqua Sciences, Inc. · Feb 2011
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
K093608 · Gambro Renal Products, Inc. · Jul 2010
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K083712 · Dipure, LLC · Jul 2009
NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
K090885 · Nephros, Inc. · Jun 2009
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
K082400 · Culligan Soft Water Service Co. · Feb 2009