510(k) · Cleared
Recalled · Class II · 20262008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
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 Jun 13, 2025 as substantially equivalent to K231125 (Fresenius Medical Care Renal Therapies Group, LLC, 2023) after a 246-day review. Its family tree reaches back 12 generations to 1994. 2 of the 21 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Jun 13, 2025
- Review
- 246 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 12 generations to K921456 (1994). 20 ancestors in all, the oldest K873155 (1987). No later device cites it as a predicate yet. 2 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 8 generations between
- 3 generations backK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- 2 generations backK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- 1 generation backK231125 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
- This deviceK243237 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag…Fresenius Medical Care Renal Therapies Group, LLC · 2025
Show all 12 generations
- Root · 12 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 11 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 10 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 9 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 8 generations backK101715 Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · Recalled
- 7 generations backK120017 Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- 6 generations backK121341 Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- 5 generations backK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
- 4 generations backK150708 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T…Fresenius Medical Care Renal Therapies Group, LLC · 2015 · Recalled (Class I)
- 3 generations backK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- 2 generations backK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- 1 generation backK231125 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
- This deviceK243237 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag…Fresenius Medical Care Renal Therapies Group, LLC · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −11 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −10 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −9 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −8 | K101715 | Fresenius 2008T Hemodialysis Machine Model 190573 | Fresenius Medical Care North America, Design Cente | 2010 | 1 |
| −7 | K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 3 |
| −6 | K121341 | Fresenius 2008T Hemodialysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 5 |
| −5 | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | — |
| −4 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T… | Fresenius Medical Care Renal Therapies Group, LLC | 2015 | Class I |
| −3 | K153449 | 2008K2 Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2016 | 2 |
| −2 | K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | Class I |
| −1 | K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 4 |
| 0 (this device) | K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K231125 | 2008T BlueStar Hemodialysis MachineSummary page 5…ithout sealed dialysate system FDA Review Panel: Gastroenterology/Urology 1.3. Legally Marketed Predicate Device The 2008T BlueStar Hemodialysis Machine (K231125) is the legally marketed predicate device. 1.4. Device Description 1.4.1. Device Identification The device is identi… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2026 | Class II | Z-3017-2026 | Process control | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis machines. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 2 generations back · ◆ on the line of descent in FIG. 18 Class I recalls
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 4 generations back · ◆ on the line of descent in FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 20 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K231125.
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?
2008T BlueStar Hemodialysis Machine: The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing = 20 kg and =40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy…
Read the full statement (283 words)
2008T BlueStar Hemodialysis Machine: The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing = 20 kg and =40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing < 40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.
bibag System (Optional):
The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician’s prescription.
Crit-Line Clip Monitor (CLiC) (Optional):
The Crit-Line Clip Monitor is used with the 2008T BlueStar Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
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/K243237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243237: 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243237
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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