510(k) · Cleared
ClearedBiopure HX2 Reverse Osmosis Water Purification System
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 Apr 30, 2014 as substantially equivalent to K030348 (Biolab Equipment Canada, Ltd., 2003) and 1 other predicate after a 195-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Apr 30, 2014
- Review
- 195 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K811678 (1981). 8 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 deviceK133149 Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2014
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) | K133149 | Biopure HX2 Reverse Osmosis Water Purification System | Mar Cor Purification, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K030348 | Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO…Summary page 3…ted States The RioPure is equivalent in function and indications to the Mar Cor's (formerly Biolab Equipment Canada Ltd.) - 4400 HX Water purification system (1(030348) and Mar Cor's Milleniumn HX Portable Reverse Osmosis water Purification System (KI 110578). Both the subject and predicate devi… | 2003 |
| * | K110578 | Millenium HX Portable Reverse Osmosis Water Purification SystemSummary page 3…y Biolab Equipment Canada Ltd.) - 4400 HX Water purification system (1(030348) and Mar Cor's Milleniumn HX Portable Reverse Osmosis water Purification System (KI 110578). Both the subject and predicate devices have the same intended use, principle of operation and basic functions. All devices hav… | 2011 |
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 33 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K030348.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 BioPure HX2 Reverse Osmosis water purification system is designed to purify pre-treated water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. BioPure HX2 is intended for use in water…
Read the full statement (143 words)
The BioPure HX2 Reverse Osmosis water purification system is designed to purify pre-treated water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. BioPure HX2 is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat disinfection process.
The BioPure HX2 is available two different double pass configurations that supply 5 gallons per minute (gpm) and 11 gpm. Version HX2P-05 is a double pass triple membrane RO that produces up to 5 gpm of product water. Version HX2P-11 is a double pass six membrane RO that produces up to 11 gpm of product water.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133149: Biopure HX2 Reverse Osmosis Water Purification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133149
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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