Cleared Traditional

K131904 - MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA

K131904 is an FDA 510(k) clearance for MEDIQA SINGLE PASS REVERSE OSMOSIS SYST..., 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 141-day FDA review.

K131904 · Ameriwater · Gastroenterology & Urology device
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Nov 2013
Decision
141d
Days
Class 2
Risk

K131904 is an FDA 510(k) clearance for the MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUB.... Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Ameriwater (Dayton, US). The FDA issued a Cleared decision on November 13, 2013 after a review of 141 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 - K131904

510(k) Number K131904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2013
Decision Date November 13, 2013
Days to Decision 141 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
10d slower than avg
Panel avg: 131d · This submission: 141d
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 K131904.
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
AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
K133783 · Ameriwater · Apr 2014
MROZ REVERSE OSMOSIS SYSTEM
K131622 · Ameriwater · Sep 2013
DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
K123282 · Ultrapure & Industrial Services, LLC · Apr 2013
AQUABOSS ECORO DIA I (HT)
K124059 · Lauer Membran Wassertechnik GmbH · Mar 2013