Cleared Special

K223656 - AmeriWater MediQA Reverse Osmosis System (MSP3HF) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223656 · AmeriWater, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
69d
Days
Class 2
Risk

K223656 is an FDA 510(k) clearance for the AmeriWater MediQA Reverse Osmosis System (MSP3HF). Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by AmeriWater, LLC (Dayton, US). The FDA issued a Cleared decision on February 13, 2023 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all AmeriWater, LLC devices

Submission Details

510(k) Number K223656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2022
Decision Date February 13, 2023
Days to Decision 69 days
Submission Type Special
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
61d faster than avg
Panel avg: 130d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

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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