Cleared Traditional

HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 (K092481) - FDA 510(k) Clearance

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

K092481 · New Aqua, LLC (Dba Aqua Systems) · Gastroenterology & Urology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 130d · This submission: 232d
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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