510(k) · Cleared
ClearedOlpur Dialyzer, Model HD 190
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 Jun 9, 2005 as substantially equivalent to K982414 (Gambro Healthcare, 1999) and 1 other predicate after a 92-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Jun 9, 2005
- Review
- 92 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955592 (1997). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
- 1 generation backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
- This deviceK050603 Olpur Dialyzer, Model HD 190Nephros, Inc. · 2005
- 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 · 4 generations on · 0 of its ownK251851 DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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
- K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955592 | Cobe Centrysystem 14 Pes Hemodialyzers | Cobe Renal Care, Inc. | 1997 | — |
| −1 | K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters | Gambro Healthcare | 1999 | — |
| 0 (this device) | 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 | — |
| +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 | — |
| +4 | K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersSummary page 1…ialyzer Identification of predicate device(s)- The OLpa~r HD 190 Dialyzer is substantially equivalent to the following devices: Gambro Polyflux 21S Dialyzer, 510(k) # K982414 Asahi APS 21 R Dialyzer, 5 10(k) # KOO 1250 Description of the device The OLpflrTm HD 190 Dialyzer is a sterile, non-pyrogeni… | 1999 |
| * | K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) | 2000 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112314 | Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter | 2012 | 5 |
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 8 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K112314 (Nephros, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K982414.
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.
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 OLpjr TM HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050603: Olpur Dialyzer, Model HD 190.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050603
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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