510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Millenium HX Portable Reverse Osmosis Water Purification System

K110578510(k) TraditionalCleared May 20, 201180-day reviewClass II21 CFR 876.5665Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mar Cor Purification, Inc. · FIP Subsystem, Water Purification

Cleared on May 20, 2011 as substantially equivalent to K093608 (Gambro Renal Products, Inc., 2010) and 2 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1981. 6 later devices descend from it. It has been recalled once.

Decided
May 20, 2011
Review
80 days
Class
Class II
Product code
FIP
Recalls
1
Predicates
3

Its longest line of descent runs back 3 generations to K811678 (1981). 5 ancestors in all. 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1997: 1 other ancestor2014: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2015: 1 descendant cleared2025: 1 descendant cleared2020: 1 descendant clearedK811678 · Gambro Water Purification Monitor WRD · Gambro, Inc. · 1981K042797 · Wro 300 Water Purification System for Hemodialysis · Gambro Renal Products · 2005K093608 · Gambro Water Purification Unit, Models Wro 300 and Wro 300 H · Gambro Renal Products, Inc. · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants K093608 · Gambro Water Purification Unit, Models Wro 300 and Wro 300 H · Gambro Renal Products, Inc. · 2010K042797 · Wro 300 Water Purification System for Hemodialysis · Gambro Renal Products · 2005K811678 · Gambro Water Purification Monitor WRD · Gambro, Inc. · 19810
  1. Root · 3 generations backK811678 Gambro Water Purification Monitor WRDGambro, Inc. · 1981
  2. 2 generations backK042797 Wro 300 Water Purification System for HemodialysisGambro Renal Products · 2005
  3. 1 generation backK093608 Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc. · 2010
  4. This deviceK110578 Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2011
  5. Descendant · cites it directly · 1 of its ownK171099 EON Portable Reverse Osmosis Water Purification SystemCantel · 2018
  6. Descendant · cites it directly · 1 of its ownK143617 AquaC UNO HVivonic GmbH · 2015 · Recalled
  7. Descendant · 2 generations on · 0 of its ownK250471 AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC · 2025
  8. Descendant · 2 generations on · 0 of its ownK200670 EON Portable RO Water Purification SystemMar Cor Purification, Inc. · 2020
  9. Descendant · cites it directly · 0 of its ownK192398 Millenium HXMar Cor Purification, Inc. · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12018: 12019: 12020: 12025: 1
2014high 1 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all
  • K171099EON Portable Reverse Osmosis Water Purification SystemCantel · 2018 · cites it directly1descendant
  • K143617AquaC UNO HVivonic GmbH · 2015 · cites it directly1descendant
  • K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on0descendants
  • K200670EON Portable RO Water Purification SystemMar Cor Purification, Inc. · 2020 · 2 generations on0descendants
  • K192398Millenium HXMar Cor Purification, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K811678Gambro Water Purification Monitor WRDGambro, Inc.1981—
−2K042797Wro 300 Water Purification System for HemodialysisGambro Renal Products2005—
−1K093608Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc.2010—
0 (this device)K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc.2011—
+1K171099EON Portable Reverse Osmosis Water Purification SystemCantel2018—
+1K143617AquaC UNO HVivonic GmbH20155
+2K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC2025—
+2K200670EON Portable RO Water Purification SystemMar Cor Purification, Inc.2020—
+1K192398Millenium HXMar Cor Purification, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201810
201910
202010
202510
FIG. 1 — Lineage of K110578, 1981–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FIP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FIP device

  1. #1 K251851 DIASAFEplusUS (F00013010)score 14.1 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K093608Gambro Water Purification Unit, Models Wro 300 and Wro 300 H
Summary page 2
…ther Devices in Commercial Distribution Within the United States The Milleniumn HX is equivalent in function and indications to the Mar Cor (formerly Gamnbro) WRO 300H (K093608), the Mar Cor Semper Pure RO system (K003 877) and the Mar Cor Millenium Portable RO System 750 (K96453 9). All of the products a…
Gambro Renal Products, Inc.2010—
*K003877Mar Cor Services Semper Pure RO Machine
Summary page 2
…n the United States The Milleniumn HX is equivalent in function and indications to the Mar Cor (formerly Gamnbro) WRO 300H (K093608), the Mar Cor Semper Pure RO system (K003 877) and the Mar Cor Millenium Portable RO System 750 (K96453 9). All of the products are portable reverse osmosis water purification…
Mar Cor Services, Inc.2001—
*K964539Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802…
Summary page 2
…tion and indications to the Mar Cor (formerly Gamnbro) WRO 300H (K093608), the Mar Cor Semper Pure RO system (K003 877) and the Mar Cor Millenium Portable RO System 750 (K96453 9). All of the products are portable reverse osmosis water purification systems with the same intended use and equivalent indicatio…
Zyzatech Water Systems, Inc.1997—

Also cleared against K093608: 4 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171099EON Portable Reverse Osmosis Water Purification SystemCantel20181
K143617AquaC UNO HVivonic GmbH20151
K192398Millenium HXMar Cor Purification, Inc.20190
K133149Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc.20140

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 26, 2013Class IIZ-1213-2014Component design/selectionHigh inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K171099 (Cantel, 2018) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K093608.

How does its category compare?

All FIP devices

FIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · FIP

4in 2025

2007: 12008: 32009: 32010: 22011: 42012: 22013: 42014: 42015: 22016: 22017: 12018: 12019: 22020: 12021: 12022: 12023: 32024: 12025: 4
2007high 4 (2011) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FIP

88in 2025

2008: 202 days median2009: 167 days median2011: 116 days median2013: 125 days median2014: 126 days median2023: 69 days median2025: 88 days median
2007high 202 (2008) · low 69 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FIP

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FIP

77in 2025

2007: 12008: 52010: 122011: 42012: 42013: 412014: 342015: 122016: 32017: 62018: 32019: 132020: 122021: 352022: 572023: 1402024: 1742025: 77
2007high 174 (2024) · low 0 (2009)2025

MAUDE reports naming product code FIP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
2008320205
2009316700
20102—012
2011411604
20122—04
20134125041
20144126034
20152—012
20162—03
20171—06
20181—03
20192—013
20201—112
20211—035
20221—057
20233690140
20241—0174
2025488077
20260—0—

What is it indicated for?

The Mar Cor Purification Millenium HX Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment.

The Millenium HX can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAML and Federal (U.S) standards.

Indications for use as stated in the FDA summary.

Also cleared against K093608

4 other devices cite the same predicate.

  • K200670EON Portable RO Water Purification SystemMar Cor Purification, Inc. · 2020
  • K192398Millenium HXMar Cor Purification, Inc. · 2019
  • K143617AquaC UNO HVivonic GmbH · 20155 recalls
  • K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013

More from Mar Cor Purification, Inc.

4 FDA decisions under this applicant name. See the company

  • K200670EON Portable RO Water Purification SystemMar Cor Purification, Inc. · 2020
  • K192398Millenium HXMar Cor Purification, Inc. · 2019
  • K133149Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2014

Recent decisions in FIP

The FIP category page

  • K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC · 2025
  • K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025
  • K252181AquaAFresenius Medical Care North America · 2025
  • K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc. · 2025
  • K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC · 2024

https://510kreport.com/device/K110578 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110578: Millenium HX Portable Reverse Osmosis Water Purification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110578

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026