Cleared Abbreviated

K051620 - MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES

K051620 is an FDA 510(k) clearance for MATRIX DIGITAL REVERSE OSMOSIS WATER TR..., manufactured by Better Water, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Abbreviated 510(k) pathway after a 154-day FDA review.

K051620 · Better Water, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
154d
Days
Class 2
Risk

K051620 is an FDA 510(k) clearance for the MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Better Water, Inc. (Smyrna, US). The FDA issued a Cleared decision on November 18, 2005 after a review of 154 days - an extended review cycle.

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 Better Water, Inc. devices

FDA 510(k) Submission Details - K051620

510(k) Number K051620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2005
Decision Date November 18, 2005
Days to Decision 154 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
23d slower than avg
Panel avg: 131d · This submission: 154d
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
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K051620.
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
K071104 · Flier'S Quality Water Systems, Inc. · Jan 2008
GAMBRO POSICLEAR
K061782 · Gambro Services, Inc. · Jan 2007
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K060942 · Bob J. Johnson & Associates · Jul 2006
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
K042018 · Simply Clean Air & Water, Inc. · Apr 2005
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
K043344 · Dialysis Services, Inc. · Mar 2005
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K042797 · Gambro Renal Products · Mar 2005