510(k) · Cleared
ClearedUltrapure Water Treatment System for Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dayton Water Systems · FIP Subsystem, Water Purification
Cleared on Dec 31, 1998 as substantially equivalent to K920186 (Better Water, Inc., 1995) after a 232-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Dec 31, 1998
- Review
- 232 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920186 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK920186 Water Purification System for HemodialysisBetter Water, Inc. · 1995
- This deviceK981680 Ultrapure Water Treatment System for HemodialysisDayton Water Systems · 1998
- Descendant · cites it directly · 0 of its ownK991916 Virginia Water Systems' Water Purification System for HemodialysisVirginia Water Systems, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K991916Virginia Water Systems' Water Purification System for HemodialysisVirginia Water Systems, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920186 | Water Purification System for Hemodialysis | Better Water, Inc. | 1995 | — |
| 0 (this device) | K981680 | Ultrapure Water Treatment System for Hemodialysis | Dayton Water Systems | 1998 | — |
| +1 | 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 |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K920186 | Water Purification System for HemodialysisSummary page 1…Dayton Water Systems' UltraPure Water Treatment System for Hemodialysis Claiming substantial equivalence to: Better Water Inc. Water Treatment System for Hemodialysis (K920186) Intended Use: Dayton Water Systems' UltraPure Water Treatiment System for Hemodialysis is intended for use in hemodialysis trea… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991916 | Virginia Water Systems' Water Purification System for Hemodialysis | 2000 | 0 |
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?
Dayton Water Systems’ UltraPure Water Treatment System for Hemodialysis is intended for use in hemodialysis treatment. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
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/K981680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981680: Ultrapure Water Treatment System for Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981680
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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