510(k) · Cleared
ClearedMillenium HX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mar Cor Purification, Inc. · FIP Subsystem, Water Purification
Cleared on Oct 3, 2019 as substantially equivalent to K110578 (Mar Cor Purification, Inc., 2011) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Oct 3, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K811678 (1981). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK811678 Gambro Water Purification Monitor WRDGambro, Inc. · 1981
- 3 generations backK042797 Wro 300 Water Purification System for HemodialysisGambro Renal Products · 2005
- 2 generations backK093608 Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc. · 2010
- 1 generation backK110578 Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2011 · Recalled
- This deviceK192398 Millenium HXMar Cor Purification, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811678 | Gambro Water Purification Monitor WRD | Gambro, Inc. | 1981 | — |
| −3 | K042797 | Wro 300 Water Purification System for Hemodialysis | Gambro Renal Products | 2005 | — |
| −2 | K093608 | Gambro Water Purification Unit, Models Wro 300 and Wro 300 H | Gambro Renal Products, Inc. | 2010 | — |
| −1 | K110578 | Millenium HX Portable Reverse Osmosis Water Purification System | Mar Cor Purification, Inc. | 2011 | 1 |
| 0 (this device) | K192398 | Millenium HX | Mar Cor Purification, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
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 K251851 DIASAFEplusUS (F00013010)score 14.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110578 | Millenium HX Portable Reverse Osmosis Water Purification SystemSummary page 4…alence of the Millenium HX Portable Reverse Osmosis Water Purification System to its predicates – Millenium HX Portable Reverse Osmosis Water Purification System, 510(k) K110578 and WRO 300H, 510(k) K093608 – both currently cleared for sale in the U.S. 1. Device Description The device is a portable wat… | 2011 |
| * | K093608 | Gambro Water Purification Unit, Models Wro 300 and Wro 300 HSummary page 4…rtable Reverse Osmosis Water Purification System to its predicates – Millenium HX Portable Reverse Osmosis Water Purification System, 510(k) K110578 and WRO 300H, 510(k) K093608 – both currently cleared for sale in the U.S. 1. Device Description The device is a portable water purification system that u… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 4 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 3 other devices also cite its predicate K110578.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FIP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIP
77in 2025
MAUDE reports naming product code FIP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 3 | 202 | 0 | 5 |
| 2009 | 3 | 167 | 0 | 0 |
| 2010 | 2 | — | 0 | 12 |
| 2011 | 4 | 116 | 0 | 4 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 4 | 125 | 0 | 41 |
| 2014 | 4 | 126 | 0 | 34 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 13 |
| 2020 | 1 | — | 1 | 12 |
| 2021 | 1 | — | 0 | 35 |
| 2022 | 1 | — | 0 | 57 |
| 2023 | 3 | 69 | 0 | 140 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 88 | 0 | 77 |
| 2026 | 0 | — | 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 AAMI and Federal (U.S) standards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192398: Millenium HX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192398
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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