510(k) · Cleared
Recalled · 2011Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isopure, Corp. · FIP Subsystem, Water Purification
Cleared on Oct 7, 2004 after a 157-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 7, 2004
- Review
- 157 days
- Class
- Class II
- Product code
- FIP
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK041163 Isopure Complete Water System for Hemodialysis, MD 400 and MD 600…Isopure, Corp. · 2004
- Descendant · cites it directly · 3 of its ownK051620 Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd…Better Water, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK151637 UPT Series Medical RO Water SystemSpecialty Water Technologies · 2015
- Descendant · cites it directly · 0 of its ownK250514 UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK161844 Matrix Pre-Treatment ControllerBetter Water, LLC · 2016
Most influential descendants
Showing 4 of 4 · See all- K051620Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd SeriesBetter Water, Inc. · 2005 · cites it directly3descendants
- K151637UPT Series Medical RO Water SystemSpecialty Water Technologies · 2015 · cites it directly1descendant
- K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc. · 2025 · cites it directly0descendants
- K161844Matrix Pre-Treatment ControllerBetter Water, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041163 | Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series | Isopure, Corp. | 2004 | — |
| +1 | K051620 | Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series | Better Water, Inc. | 2005 | — |
| +1 | K151637 | UPT Series Medical RO Water System | Specialty Water Technologies | 2015 | — |
| +1 | K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | 2025 | — |
| +1 | K161844 | Matrix Pre-Treatment Controller | Better Water, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2011 | Not classified | Z-0190-2012 | Employee error | The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051620 (Better Water, Inc., 2005) has gone furthest, with 3 descendants of its own.
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 Isopure Complete Water Purification System each device is intended for use in Hemodialysis systems and is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. These systems are to be use in Hospitals and/or Hemodialysis facilities. Each indirect feed model has the following optional configuration: MD61 0 - Single distribution pump with a series of…
Read the full statement (195 words)
The Isopure Complete Water Purification System each device is intended for use in Hemodialysis systems and is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. These systems are to be use in Hospitals and/or Hemodialysis facilities.
Each indirect feed model has the following optional configuration:
MD61 0 - Single distribution pump with a series of ultra-filters based on the required flow of the facility. The MD610 has no Deionization capabilities.
MD620 - Dual multi-stage distribution pumps with a series of ultra-filters based on the required flow of the facility. The MD620 has no Deionization capabilities.
MD630 - Single multi-stage distribution pump with a series of ultra-filters based on the required flow of the facility. The MD630 is equipped to process a single bank of medical grade Deionization exchange tanks.
MD640 - Dual multistage distribution pumps with automatic pump alternation with a series of ultra-filters based on the required flow of the facility. The MD640 is equipped to process dual banks of medical grade Deionization exchange tanks. The MD640 is capable of operating continuously by automatically alternating between the two banks of exchange tanks.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041163: Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041163
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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