Cleared Traditional

K141213 - AMERIWATER OZONE DISINFECTION SYSTEM

K141213 is an FDA 510(k) clearance for AMERIWATER OZONE DISINFECTION SYSTEM, manufactured by Ameriwater. The device is a Class 2 Gastroenterology & Urology device with product code FIN cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K141213 · Ameriwater · Gastroenterology & Urology device
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Dec 2014
Decision
212d
Days
Class 2
Risk

K141213 is an FDA 510(k) clearance for the AMERIWATER OZONE DISINFECTION SYSTEM. Classified as Tank, Holding, Dialysis (product code FIN), Class II - Special Controls.

Submitted by Ameriwater (Dayton, US). The FDA issued a Cleared decision on December 10, 2014 after a review of 212 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Ameriwater devices

FDA 510(k) Submission Details - K141213

510(k) Number K141213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2014
Decision Date December 10, 2014
Days to Decision 212 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
81d slower than avg
Panel avg: 131d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIN Device Classification - Class 2, Special Controls

Product Code FIN Tank, Holding, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FIN Tank, Holding, Dialysis

All 11
Devices cleared under the same product code (FIN) and FDA review panel - the closest regulatory comparables to K141213.
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
K140984 · Tango3, LLC · Jan 2015
BICARB MIXING AND DISTRIBUTION SYSTEM
K112427 · Isopure, Corp. · Jan 2012
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
K093641 · Tango3, LLC · Dec 2010
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
K060333 · Dialysis Services, Inc. · Sep 2006
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
K051031 · Ameriwater · Jan 2006
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
K993272 · Pure Water, Inc. · Apr 2000