510(k) · Cleared
ClearedBiopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO System,Biopure Water Purfication Pretre
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolab Equipment Canada, Ltd. · FIP Subsystem, Water Purification
Cleared on Oct 21, 2003 as substantially equivalent to K964539 (Zyzatech Water Systems, Inc., 1997) and 1 other predicate after a 260-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Oct 21, 2003
- Review
- 260 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964539 (1997). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964539 Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704…Zyzatech Water Systems, Inc. · 1997
- This deviceK030348 Biopure Portable RO System,Biopure 4400 Series RO System, Biopure…Biolab Equipment Canada, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK133149 Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK112331 Biopure Portable RO SystemsArion Water, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964539 | Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF… | Zyzatech Water Systems, Inc. | 1997 | — |
| 0 (this device) | K030348 | Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series… | Biolab Equipment Canada, Ltd. | 2003 | — |
| +1 | K133149 | Biopure HX2 Reverse Osmosis Water Purification System | Mar Cor Purification, Inc. | 2014 | — |
| +1 | K112331 | Biopure Portable RO Systems | Arion Water, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K964539 | Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802…Summary page 2…reatment components, and product water components are substantially equivalent to the following legally marketed devices: Zyzatech Series RO systems, K964539 US Filter Water Purification System, K980182 These devices use reverse osmosis technology to purify water for… | 1997 |
| * | K980182 | Water Purification System for HemodialysisSummary page 2…substantially equivalent to the following legally marketed devices: Zyzatech Series RO systems, K964539 US Filter Water Purification System, K980182 These devices use reverse osmosis technology to purify water for hemodialysis applications. Biolab5 1OKPremarketSub… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 device is intended to remove organic and inorganic substances arid microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for dialyzer reprocessing, and equipment rinse and disinfection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030348: Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO System,Biopure Water Purfication Pretre.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030348
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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