Cleared Traditional

K110578 - MILLENIUM HX PORTABLE REVERSE OSMOSIS W...

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

K110578 · Mar Cor Purification, Inc. · Gastroenterology & Urology device
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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.

View all Mar Cor Purification, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - FIP Subsystem, Water Purification

All 20
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K110578.
Millenium HX
K192398 · Mar Cor Purification, Inc. · Oct 2019
DIASAFEplusUS
K182367 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2019
EON Portable Reverse Osmosis Water Purification System
K171099 · Cantel · Jan 2018
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · Fresenius USA, Inc. · Nov 1995
ASCORBIC ACID
K842215 · Organon Teknika Corp. · Aug 1984