510(k) · Cleared
ClearedBiopure Portable RO Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arion Water, Inc. · FIP Subsystem, Water Purification
Cleared on Jul 5, 2012 as substantially equivalent to K030348 (Biolab Equipment Canada, Ltd., 2003) and 1 other predicate after a 328-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jul 5, 2012
- Review
- 328 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964539 (1997). 5 ancestors in all, the oldest K920186 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK964539 Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704…Zyzatech Water Systems, Inc. · 1997
- 1 generation backK030348 Biopure Portable RO System,Biopure 4400 Series RO System, Biopure…Biolab Equipment Canada, Ltd. · 2003
- This deviceK112331 Biopure Portable RO SystemsArion Water, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964539 | Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF… | Zyzatech Water Systems, Inc. | 1997 | — |
| −1 | K030348 | Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series… | Biolab Equipment Canada, Ltd. | 2003 | — |
| 0 (this device) | K112331 | Biopure Portable RO Systems | Arion Water, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 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 14.1 · 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 2…Section 4.3.1: Predicate Device #1: Company: Biolab Equipment Canada Limited 510(k) Number K030348 Common Name: Reverse Osmosis systems with pr… | 2003 |
| * | K033648 | Performance Water Treatment SystemSummary page 3…Section 4.3.2: Predicate Device #2: Company: Performance Water Systems, LCC 510(k) Number: K033648 Common Name: Complete Water Treatment System with… | 2004 |
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 15 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 5 ancestors has a recall.
- 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. 2012, 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 Anion Dialysis Water System is for use in multi-patient hemodialysis. The system consists of pretreatment, reverse osmosis, post-treatment and distribution equipment. The sizing of the system is consisting with the demand of water needed for patients. The water produced will meet the minimum requirements of ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD52:2004 and R062:2006/A1 :2009) and the CMVS…
Read the full statement (111 words)
The Anion Dialysis Water System is for use in multi-patient hemodialysis. The system consists of pretreatment, reverse osmosis, post-treatment and distribution equipment. The sizing of the system is consisting with the demand of water needed for patients. The water produced will meet the minimum requirements of ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD52:2004 and R062:2006/A1 :2009) and the CMVS End Stage Renal Disease (ESRD) Program Interpretive Guidance (based on 42 CFR 494) when used as directed. RO and Pretreatment design is based off of feed water quality to meet the stated specifications. This system is intended to be used in hospitals, dialysis centers, and dialysis clinics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112331 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112331: Biopure Portable RO Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112331
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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