510(k) · Cleared
ClearedFX CorAL 40; FX CorAL 50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Dec 18, 2025 as substantially equivalent to K242053 (Fresenius Medical Care Renal Therapies Group, LLC, 2025) and 1 other predicate after a 36-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Dec 18, 2025
- Review
- 36 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K001283 (2001). 39 ancestors in all, the oldest K872364 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 9 generations between
- 3 generations backK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
- 2 generations backK220721 FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- 1 generation backK243874 FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100…Fresenius Medical Care Renal Therapies Group, LLC · 2025
- This deviceK253518 FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC · 2025
Show all 13 generations
- Root · 13 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 12 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 11 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- 10 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- 9 generations backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- 8 generations backK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
- 7 generations backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
- 6 generations backK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
- 5 generations backK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
- 4 generations backK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
- 3 generations backK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
- 2 generations backK220721 FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- 1 generation backK243874 FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100…Fresenius Medical Care Renal Therapies Group, LLC · 2025
- This deviceK253518 FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −12 | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −11 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| −10 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| −9 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| −8 | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | 2 |
| −7 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
| −6 | K082414 | Optiflux F250NR, Model 0500325E | Fresenius Medical Care North America | 2008 | 3 |
| −5 | K123262 | Optiflux Ultra Dialyzer | Fresenius Medical Care North America | 2014 | — |
| −4 | K152367 | Optiflux dialyzer | Fresenius Medical Care North America | 2015 | 1 |
| −3 | K162488 | Optiflux dialyzer | Fresenius Medical Care North America | 2017 | 4 |
| −2 | K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL… | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | — |
| −1 | K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
| 0 (this device) | K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Summary page 5…Gastroenterology/Urology 1.3. Legally Marketed Predicate Device The legally marketed primary predicate devices are the FX CorAL 40 and 50 dialyzers cleared under K242053. The secondary predicate devices are the FX CorAL 60, 80, 100, 120, 600, 800, and 1000 dialyzers (K243874). These predicates have… | 2025 |
| * | K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Summary page 5…cate devices are the FX CorAL 40 and 50 dialyzers cleared under K242053. The secondary predicate devices are the FX CorAL 60, 80, 100, 120, 600, 800, and 1000 dialyzers (K243874). These predicates have not been subject to design-related recalls. 1.4. Device Description 1.4.1. Device Identifica… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 39 ancestors have a recall of any class.
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. 2025, 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 FX CorAL hemodialyzers are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency, including pediatric patients.
Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253518: FX CorAL 40; FX CorAL 50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253518
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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