Cleared Traditional

K102892 - ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

K102892 is an FDA 510(k) clearance for ASI DEIONIZER & CARBON EXCHANGE SERVICE..., manufactured by Aqua Sciences, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K102892 · Aqua Sciences, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
126d
Days
Class 2
Risk

K102892 is an FDA 510(k) clearance for the ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Aqua Sciences, Inc. (Tonawanda, US). The FDA issued a Cleared decision on February 3, 2011 after a review of 126 days - within the typical 510(k) review window.

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 Sciences, Inc. devices

FDA 510(k) Submission Details - K102892

510(k) Number K102892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date February 03, 2011
Days to Decision 126 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 131d · This submission: 126d
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 K102892.
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
K111740 · Ameriwater · Oct 2011
NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
K110285 · Nephros, Inc. · Jul 2011
MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K110578 · Mar Cor Purification, Inc. · May 2011
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
K093608 · Gambro Renal Products, Inc. · Jul 2010
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
K092481 · New Aqua, LLC (Dba Aqua Systems) · Apr 2010
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K083712 · Dipure, LLC · Jul 2009