510(k) · Cleared
ClearedHD-400-a/B/C Hemodialysis Systems & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Water Pure, Inc. · FIP Subsystem, Water Purification
Cleared on Oct 23, 1987 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 23, 1987
- Review
- 53 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK873487 HD-400-a/B/C Hemodialysis Systems & AccessoriesWater Pure, Inc. · 1987
- Descendant · cites it directly · 5 of its ownK945559 Mar Cor Complete Water Treatment System for Kdney DialysisMar Cor Services, Inc. · 1996
- Descendant · 2 generations on · 1 of its ownK994292 Water Purification SystemWater & Power Technologies, Inc. · 2001
- Descendant · 3 generations on · 0 of its ownK042089 NX Stage Water Purification SystemNxstage Medical, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK994279 Pure Water-CDS (Central Dialysis Solution)Pure Water Solutions, Inc. · 2000
- Descendant · 2 generations on · 0 of its ownK991916 Virginia Water Systems' Water Purification System for HemodialysisVirginia Water Systems, Inc. · 2000
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K945559Mar Cor Complete Water Treatment System for Kdney DialysisMar Cor Services, Inc. · 1996 · cites it directly5descendants
- K994292Water Purification SystemWater & Power Technologies, Inc. · 2001 · 2 generations on1descendant
- K042089NX Stage Water Purification SystemNxstage Medical, Inc. · 2004 · 3 generations on0descendants
- K994279Pure Water-CDS (Central Dialysis Solution)Pure Water Solutions, Inc. · 2000 · 2 generations on0descendants
- K991916Virginia Water Systems' Water Purification System for HemodialysisVirginia Water Systems, Inc. · 2000 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K873487 | HD-400-a/B/C Hemodialysis Systems & Accessories | Water Pure, Inc. | 1987 | — |
| +1 | K945559 | Mar Cor Complete Water Treatment System for Kdney Dialysis | Mar Cor Services, Inc. | 1996 | — |
| +2 | K994292 | Water Purification System | Water & Power Technologies, Inc. | 2001 | — |
| +3 | K042089 | NX Stage Water Purification System | Nxstage Medical, Inc. | 2004 | — |
| +2 | K994279 | Pure Water-CDS (Central Dialysis Solution) | Pure Water Solutions, Inc. | 2000 | — |
| +2 | K991916 | Virginia Water Systems' Water Purification System for Hemodialysis | Virginia Water Systems, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K945559 | Mar Cor Complete Water Treatment System for Kdney Dialysis | 1996 | 5 |
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?
- Of its descendants, K945559 (Mar Cor Services, Inc., 1996) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K873487 · printed Nov 4, 2026
Cite this page
510(k) Report. “K873487: HD-400-a/B/C Hemodialysis Systems & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873487
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026