Cleared Abbreviated

K111740 - AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION

K111740 is an FDA 510(k) clearance for AMERIWATER MRO PORTABLE REVERSE OSMOSIS..., manufactured by Ameriwater. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Abbreviated 510(k) pathway after a 106-day FDA review.

K111740 · Ameriwater · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
106d
Days
Class 2
Risk

K111740 is an FDA 510(k) clearance for the AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Ameriwater (Dayton, US). The FDA issued a Cleared decision on October 5, 2011 after a review of 106 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ameriwater devices

FDA 510(k) Submission Details - K111740

510(k) Number K111740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2011
Decision Date October 05, 2011
Days to Decision 106 days
Submission Type Abbreviated
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
25d faster than avg
Panel avg: 131d · This submission: 106d
Pathway characteristics
Standards-based clearance path.

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
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