510(k) · Cleared
ClearedWater Purification System for Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Total Water Treatment Systems, Inc. · FIP Subsystem, Water Purification
Cleared on Feb 16, 2001 after a 226-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Feb 16, 2001
- Review
- 226 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK002045 Water Purification System for HemodialysisTotal Water Treatment Systems, Inc. · 2001
- Descendant · cites it directly · 10 of its ownK012716 Mainstream Water Purification DevicePrismedical Corp. · 2002
- Descendant · 2 generations on · 9 of its ownK141731 Nephros Dsu-H, Nephros Ssu-HNephros, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK153784 Nosogard FiltersEvoqua Water Technologies, LLC · 2016
- Descendant · 3 generations on · 4 of its ownK153434 Pall-Aquasafe Water FilterPall International Sarl · 2016
- Descendant · 3 generations on · 2 of its ownK153084 Nephros S100Nephros, Inc. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K012716Mainstream Water Purification DevicePrismedical Corp. · 2002 · cites it directly10descendants
- K141731Nephros Dsu-H, Nephros Ssu-HNephros, Inc. · 2014 · 2 generations on9descendants
- K153784Nosogard FiltersEvoqua Water Technologies, LLC · 2016 · 2 generations on4descendants
- K153434Pall-Aquasafe Water FilterPall International Sarl · 2016 · 3 generations on4descendants
- K153084Nephros S100Nephros, Inc. · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002045 | Water Purification System for Hemodialysis | Total Water Treatment Systems, Inc. | 2001 | — |
| +1 | K012716 | Mainstream Water Purification Device | Prismedical Corp. | 2002 | — |
| +2 | K141731 | Nephros Dsu-H, Nephros Ssu-H | Nephros, Inc. | 2014 | — |
| +2 | K153784 | Nosogard Filters | Evoqua Water Technologies, LLC | 2016 | — |
| +3 | K153434 | Pall-Aquasafe Water Filter | Pall International Sarl | 2016 | — |
| +3 | K153084 | Nephros S100 | Nephros, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (12)
See all 122 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?
- Of its descendants, K012716 (Prismedical Corp., 2002) has gone furthest, with 10 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/K002045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002045: Water Purification 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/K002045
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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