510(k) · Cleared
ClearedMar Cor Complete Water Treatment System for Kdney Dialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mar Cor Services, Inc. · FIP Subsystem, Water Purification
Cleared on May 28, 1996 as substantially equivalent to K873487 (Water Pure, Inc., 1987) and 1 other predicate after a 565-day review. Its family tree reaches back 1 generation to 1987. 5 later devices descend from it.
- Decided
- May 28, 1996
- Review
- 565 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K873487 (1987). 2 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK873487 HD-400-a/B/C Hemodialysis Systems & AccessoriesWater Pure, Inc. · 1987
- This deviceK945559 Mar Cor Complete Water Treatment System for Kdney DialysisMar Cor Services, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK994292 Water Purification SystemWater & Power Technologies, Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK042089 NX Stage Water Purification SystemNxstage Medical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK994279 Pure Water-CDS (Central Dialysis Solution)Pure Water Solutions, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK991916 Virginia Water Systems' Water Purification System for HemodialysisVirginia Water Systems, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK983512 Water Treatment System for HemodialysisWater Vault, Inc. · 1999
Most influential descendants
Showing 5 of 5 · See all- K994292Water Purification SystemWater & Power Technologies, Inc. · 2001 · cites it directly1descendant
- K042089NX Stage Water Purification SystemNxstage Medical, Inc. · 2004 · 2 generations on0descendants
- K994279Pure Water-CDS (Central Dialysis Solution)Pure Water Solutions, Inc. · 2000 · cites it directly0descendants
- K991916Virginia Water Systems' Water Purification System for HemodialysisVirginia Water Systems, Inc. · 2000 · cites it directly0descendants
- K983512Water Treatment System for HemodialysisWater Vault, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873487 | HD-400-a/B/C Hemodialysis Systems & Accessories | Water Pure, Inc. | 1987 | — |
| 0 (this device) | K945559 | Mar Cor Complete Water Treatment System for Kdney Dialysis | Mar Cor Services, Inc. | 1996 | — |
| +1 | K994292 | Water Purification System | Water & Power Technologies, Inc. | 2001 | — |
| +2 | K042089 | NX Stage Water Purification System | Nxstage Medical, Inc. | 2004 | — |
| +1 | K994279 | Pure Water-CDS (Central Dialysis Solution) | Pure Water Solutions, Inc. | 2000 | — |
| +1 | K991916 | Virginia Water Systems' Water Purification System for Hemodialysis | Virginia Water Systems, Inc. | 2000 | — |
| +1 | K983512 | Water Treatment System for Hemodialysis | Water Vault, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 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 14.0 · 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 |
|---|---|---|---|
| * | K873487 | HD-400-a/B/C Hemodialysis Systems & AccessoriesSummary page 1…veloped a complete water treatment system for kidney dialysis. This system is equivalent to such other commercial water treatment systems as the Water Pure RO System (K# 873487) and the C.D. Medical, Inc., Drake Willock RO Water Treatment System (K# 894106), and other comparable water treatment systems.… | 1987 |
| * | K894106 | Drake Willock Reverse Osmosis Water Treatment SystSummary page 1…ivalent to such other commercial water treatment systems as the Water Pure RO System (K# 873487) and the C.D. Medical, Inc., Drake Willock RO Water Treatment System (K# 894106), and other comparable water treatment systems. Mar Cor Services, Inc., is confident that this water treatment system 1is compar… | 1989 |
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K994292 (Water & Power Technologies, Inc., 2001) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K945559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945559: Mar Cor Complete Water Treatment System for Kdney Dialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945559
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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