Cleared Traditional

K110578 - MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM

K110578 is an FDA 510(k) clearance for MILLENIUM HX PORTABLE REVERSE OSMOSIS W..., manufactured by Mar Cor Purification, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K110578 · Mar Cor Purification, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
80d
Days
Class 2
Risk

K110578 is an FDA 510(k) clearance for the MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Mar Cor Purification, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 20, 2011 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K110578

510(k) Number K110578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2011
Decision Date May 20, 2011
Days to Decision 80 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
51d faster than avg
Panel avg: 131d · This submission: 80d
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 114
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K110578.
BIOPURE PORTABLE RO SYSTEMS
K112331 · Arion Water, Inc. · Jul 2012
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
K111740 · Ameriwater · Oct 2011
NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
K110285 · Nephros, Inc. · Jul 2011
ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
K102892 · Aqua Sciences, Inc. · Feb 2011
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
K093608 · Gambro Renal Products, Inc. · Jul 2010
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
K092481 · New Aqua, LLC (Dba Aqua Systems) · Apr 2010
K110578 · MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
Download PDF FDA Summary Mar Cor Purification,…