510(k) · Cleared
ClearedPure Water-CDS (Central Dialysis Solution)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pure Water Solutions, Inc. · FIP Subsystem, Water Purification
Cleared on Dec 22, 2000 as substantially equivalent to K945559 (Mar Cor Services, Inc., 1996) after a 368-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Dec 22, 2000
- Review
- 368 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873487 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK873487 HD-400-a/B/C Hemodialysis Systems & AccessoriesWater Pure, Inc. · 1987
- 1 generation backK945559 Mar Cor Complete Water Treatment System for Kdney DialysisMar Cor Services, Inc. · 1996
- This deviceK994279 Pure Water-CDS (Central Dialysis Solution)Pure Water Solutions, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K994279 | Pure Water-CDS (Central Dialysis Solution) | Pure Water Solutions, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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? (1)
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 |
|---|---|---|---|
| * | K945559 | Mar Cor Complete Water Treatment System for Kdney DialysisSummary page 1…ewis Classification Name: Water Purification System for Hemodialysis Device Name: PURE WATER-CDS (Central Dialysis Solution) Predicate Device: Mar Cor Services, Inc. #K945559 Description of System: The PURE WATER Solutions” Water Purification System for Hemodialysis is designed to provide water of the… | 1996 |
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 13 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K945559.
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?
This device is intended to remove organic and inorganic substances
and 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994279: Pure Water-CDS (Central Dialysis Solution).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994279
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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