510(k) · Cleared
ClearedNephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nephros, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Apr 27, 2012 as substantially equivalent to K050603 (Nephros, Inc., 2005) and 8 other predicates after a 260-day review. Its family tree reaches back 3 generations to 1997. 5 later devices descend from it.
- Decided
- Apr 27, 2012
- Review
- 260 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 3 generations to K955592 (1997). 24 ancestors in all, the oldest K770691 (1977). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
- 2 generations backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
- 1 generation backK050603 Olpur Dialyzer, Model HD 190Nephros, Inc. · 2005
- This deviceK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
- Descendant · 2 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
- Descendant · cites it directly · 1 of its ownK210575 HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022
- Descendant · 3 generations on · 0 of its ownK251851 DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK233557 HemoCare Hemodialysis SystemDeka Research and Development · 2024
Most influential descendants
Showing 5 of 5 · See all- K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · cites it directly2descendants
- K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on1descendant
- K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022 · cites it directly1descendant
- K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on0descendants
- K233557HemoCare Hemodialysis SystemDeka Research and Development · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955592 | Cobe Centrysystem 14 Pes Hemodialyzers | Cobe Renal Care, Inc. | 1997 | — |
| −2 | K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters | Gambro Healthcare | 1999 | — |
| −1 | K050603 | Olpur Dialyzer, Model HD 190 | Nephros, Inc. | 2005 | — |
| 0 (this device) | K112314 | Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter | Nephros, Inc. | 2012 | — |
| +1 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 1 |
| +2 | K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 6 |
| +1 | K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | Nephros | 2022 | — |
| +3 | K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (9)
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 |
|---|---|---|---|
| * | K050603 | Olpur Dialyzer, Model HD 190Summary page 1…PIP, KDI Predicate Devices > Predicate for the Nephros MD 220 Hemodiafilter - Nephros OLprjr HDI90 (K050603) > Predicate for the H2H Module with qualified UIF-… | 2005 |
| * | K010131 | PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Summary page 1…ualified UIF- Controlled Hemodialysis Machine - Aksys PHD Personal Hemodialysis System (K010131) > Predicate for the H2H Module in the stand-alone… | 2002 |
| * | K090885 | Nephros, Inc., Dsu Dual Stage UltrafilterSummary page 1…> Predicates for the H2H Substitution Fluid Filter - Nephros DSU Dual Stage Ultrafilter (K090885), Minntech Nephros_51OkK1 12314_RFI Response-2 Privileged and Confidential Page 573 of 579 === P… | 2009 |
| * | K945136 | Renaguard Dialysate FilterSummary page 2…A 2z1s Renaguard Dialysate Filter (K945136), Gambro Diaclear Ultrafilter (K003957), Fresenius Citric Acid Dialyzer… | 1995 |
| * | K003957 | Diaclear UltrafilterSummary page 2…A 2z1s Renaguard Dialysate Filter (K945136), Gambro Diaclear Ultrafilter (K003957), Fresenius Citric Acid Dialyzer Reprocessing (K974090)… | 2001 |
| * | K974090 | 95 C/1.5 Citric Acid Heat Processing of Polysulfone DialyzersSummary page 2…136), Gambro Diaclear Ultrafilter (K003957), Fresenius Citric Acid Dialyzer Reprocessing (K974090) > Predicates for the H2H Water Filter - Nephros DSU Dual… | 1998 |
| * | K983126 | Fiberflo Hollow Fiber Capsule Water FiltersSummary page 2…SU Dual Stage Ultrafilter (K090885), Minntech FiberFla Hollow Fiber Capsule Water Filter (K983126) > Predicates for the Disposable H2H Infusion Line and… | 1999 |
| * | K033301 | IV Administration and Connect SetsSummary page 2…isposable H2H Infusion Line and Blood Tubing Extension Set - Codan IVAdministration Sets (K033301), Nipro Blood Tubing Set w/Transducer Protector and Priming Set (K072024) Device De… | 2004 |
| * | K072024 | Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219…Summary page 2…nistration Sets (K033301), Nipro Blood Tubing Set w/Transducer Protector and Priming Set (K072024) Device Description The H2HTh Hemodiafiltration Module is a programmable electro- mech… | 2007 |
What descends from it? (5)
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K231534 (Fresenius Medical Care, 2024) has gone furthest, with 2 descendants of its own.
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. 2012, 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 OLP~r H2H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLP~r MID 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLPOr MID 220 Hemodiafilter is only to be used with the…
Read the full statement (155 words)
The OLP~r H2H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLP~r MID 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLPOr MID 220 Hemodiafilter is only to be used with the OLpair H2H Hemodiafiltration Module. Selection of patients, as well as treatment operating parameters, are a medical decision and the responsibility of the prescribing physician.
The OLP~r H2H Hemodiafiltration (HDF) Module works in conjunction with a qualified host (UF controlled) hemodialysis machine and it's accessories (i.e., bloodlines; dialysate, concentrates, etc.), the H2H Module accessories (water and substitution fluid filters, infusion / rinse line, and optional blood extension line), appropriately prepared water and ultrapure dialysate for hemodialysis, and a high permeability hernodialyzerI hernodiafilter (i.e., the OLP~ir MD 220 Hemodiafilter).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112314
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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