510(k) · Cleared
ClearedHDF Assist Mudule, HDF Infusion Set and Substitution Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nephros · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on May 13, 2022 as substantially equivalent to K112314 (Nephros, Inc., 2012) after a 441-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- May 13, 2022
- Review
- 441 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K955592 (1997). 25 ancestors in all, the oldest K770691 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
- 3 generations backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
- 2 generations backK050603 Olpur Dialyzer, Model HD 190Nephros, Inc. · 2005
- 1 generation backK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
- This deviceK210575 HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022
- Descendant · cites it directly · 0 of its ownK233557 HemoCare Hemodialysis SystemDeka Research and Development · 2024
Most influential descendants
Showing 1 of 1 · See all- K233557HemoCare Hemodialysis SystemDeka Research and Development · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955592 | Cobe Centrysystem 14 Pes Hemodialyzers | Cobe Renal Care, Inc. | 1997 | — |
| −3 | K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters | Gambro Healthcare | 1999 | — |
| −2 | K050603 | Olpur Dialyzer, Model HD 190 | Nephros, Inc. | 2005 | — |
| −1 | K112314 | Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter | Nephros, Inc. | 2012 | — |
| 0 (this device) | K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | Nephros | 2022 | — |
| +1 | K233557 | HemoCare Hemodialysis System | Deka Research and Development | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 KDI? 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 KDI device
- #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 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 |
|---|---|---|---|
| * | K112314 | Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterSummary page 4…sification Panel Gastroenterology/Urology Predicate Information: The predicate device for the HDF Assist Module is the OLPūr™ H2H Hemodiafiltration Module, K112314, granted 04/27/2012. Device Description: The HDF Assist Module is a software controlled; electro-mechanical medical device desig… | 2012 |
| † | K944767 | Dialysis Machine with Dialysate Ultrafilter | 1995 |
| † | K182367 | DIASAFEplusUS | 2019 |
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 |
|---|---|---|---|
| K233557 | HemoCare Hemodialysis System | 2024 | 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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 4 of the 25 ancestors have a recall of any class.
- Of its descendants, K233557 (Deka Research and Development, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112314.
How does its category compare?
All KDI devicesKDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KDI
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 2025
MAUDE reports naming product code KDI, 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 | 11 | 91 | 4 | 916 |
| 2008 | 6 | 148 | 0 | 1,042 |
| 2009 | 4 | 236 | 3 | 522 |
| 2010 | 9 | 186 | 1 | 823 |
| 2011 | 5 | 85 | 4 | 2,270 |
| 2012 | 6 | 153 | 1 | 1,765 |
| 2013 | 11 | 247 | 2 | 2,360 |
| 2014 | 8 | 164 | 3 | 6,154 |
| 2015 | 5 | 69 | 5 | 4,182 |
| 2016 | 5 | 230 | 4 | 766 |
| 2017 | 8 | 188 | 1 | 963 |
| 2018 | 2 | — | 1 | 1,716 |
| 2019 | 4 | 263 | 6 | 1,587 |
| 2020 | 9 | 266 | 0 | 1,633 |
| 2021 | 2 | — | 2 | 1,944 |
| 2022 | 7 | 259 | 17 | 2,180 |
| 2023 | 7 | 157 | 8 (8) | 2,692 |
| 2024 | 7 | 235 | 4 (2) | 2,441 |
| 2025 | 9 | 199 | 2 | 2,786 |
| 2026 | 6 | 154 | 2 | — |
What is it indicated for?
The HDF Assist Module is indicated for use, with the Fresenius 2008K, 2008K2, and 2008T dialysis machines, for treatment of adult patients with acute or chronic renal failure or whenever hemodiafiltration is prescribed by a physician.
The HDF Assist Module works in conjunction with a qualified host high permeability (UF controlled) hemodialysis machine and its accessories (i.e., bloodlines, dialysate, concentrates, etc.), the HDF Assist Module accessories (HDF Infusion Set and Substitution Filter), appropriately purified water and ultrapure dialysate for hemodialysis, and a high permeability hemodialyzer / hemodiafilter (i.e., the OLPūr™ MD 220 Hemodiafilter).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210575: HDF Assist Mudule, HDF Infusion Set and Substitution Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210575
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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