Cleared Traditional

K133783 - AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION

K133783 is an FDA 510(k) clearance for AMERIWATER CENTURION 1500+ REVERSE OSMO..., manufactured by Ameriwater. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K133783 · Ameriwater · Gastroenterology & Urology device
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Apr 2014
Decision
125d
Days
Class 2
Risk

K133783 is an FDA 510(k) clearance for the AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Ameriwater (Dayton, US). The FDA issued a Cleared decision on April 16, 2014 after a review of 125 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 Ameriwater devices

FDA 510(k) Submission Details - K133783

510(k) Number K133783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2013
Decision Date April 16, 2014
Days to Decision 125 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
6d faster than avg
Panel avg: 131d · This submission: 125d
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 K133783.
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
K142285 · Ameriwater · Dec 2014
BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K133149 · Mar Cor Purification, Inc. · Apr 2014
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
K133829 · Vivonic GmbH · Apr 2014
MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA
K131904 · Ameriwater · Nov 2013
MROZ REVERSE OSMOSIS SYSTEM
K131622 · Ameriwater · Sep 2013
DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
K123282 · Ultrapure & Industrial Services, LLC · Apr 2013