510(k) · Cleared
ClearedRenaguard Dialysate Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minntech Corp. · FIP Subsystem, Water Purification
Cleared on Feb 28, 1995 after a 131-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Feb 28, 1995
- Review
- 131 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK945136 Renaguard Dialysate FilterMinntech Corp. · 1995
- Descendant · cites it directly · 5 of its ownK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
- Descendant · 3 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK210575 HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022
- Descendant · cites it directly · 1 of its ownK993806 Dialguard Endotoxin Removal DeviceClarigen, Inc. · 2000
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012 · cites it directly5descendants
- K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 2 generations on2descendants
- K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on1descendant
- K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022 · 2 generations on1descendant
- K993806Dialguard Endotoxin Removal DeviceClarigen, Inc. · 2000 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945136 | Renaguard Dialysate Filter | Minntech Corp. | 1995 | — |
| +1 | K112314 | Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter | Nephros, Inc. | 2012 | — |
| +2 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 1 |
| +3 | K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 6 |
| +2 | K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | Nephros | 2022 | — |
| +1 | K993806 | Dialguard Endotoxin Removal Device | Clarigen, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 14.0 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 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, K112314 (Nephros, Inc., 2012) 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/K945136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945136: Renaguard Dialysate Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945136
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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