510(k) · Cleared
Recalled · Class I · 20232008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
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 10, 2015 as substantially equivalent to K994267 (Fresenius Medical Care, 2000) and 2 other predicates after a 266-day review. Its family tree reaches back 8 generations to 1994. 3 of the 26 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 12 times, including 8 Class I recalls.
- Decided
- Dec 10, 2015
- Review
- 266 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 12 (8 Class I)
- Predicates
- 3
Its longest line of descent runs back 8 generations to K921456 (1994). 16 ancestors in all, the oldest K873155 (1987). 9 later devices descend from it, 1 citing it directly. 3 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 7 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 6 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 5 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 4 generations backK101715 Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · Recalled
- 3 generations backK120017 Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- 2 generations backK121341 Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- 1 generation backK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
- This deviceK150708 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T…Fresenius Medical Care Renal Therapies Group, LLC · 2015
- Descendant · cites it directly · 8 of its ownK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- Descendant · 2 generations on · 7 of its ownK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK231125 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
- Descendant · 3 generations on · 3 of its ownK222952 2008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · Recalled (Class I)
- Descendant · 4 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · cites it directly8descendants
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 2 generations on7descendants
- K2311252008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · 3 generations on4descendants
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 3 generations on3descendants
- K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −7 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −6 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −5 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −4 | K101715 | Fresenius 2008T Hemodialysis Machine Model 190573 | Fresenius Medical Care North America, Design Cente | 2010 | 1 |
| −3 | K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 3 |
| −2 | K121341 | Fresenius 2008T Hemodialysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 5 |
| −1 | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | — |
| 0 (this device) | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T… | Fresenius Medical Care Renal Therapies Group, LLC | 2015 | — |
| +1 | 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 |
| +3 | K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 4 |
| +3 | K222952 | 2008T BlueStar Hemodailysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | Class I |
| +4 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 1 |
| 2022 | 1 | 1 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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.
3 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? (3)
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 |
|---|---|---|---|
| * | K994267 | Fresenius 2008KSummary page 5…, Classification Panel: ONW/Gastroenterology–Urology 5.3. Legally Marketed Predicate Device 2008K Hemodialysis Machine K994267 2008K@home Hemodialysis Machine K124035 2008T Hemodialysis Machine… | 2000 |
| * | K124035 | 2008K@Home Hemodialysis MachineSummary page 5…Legally Marketed Predicate Device 2008K Hemodialysis Machine K994267 2008K@home Hemodialysis Machine K124035 2008T Hemodialysis Machine K131908 5.4. Device Description This section includes an expl… | 2013 |
| * | K131908 | 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Summary page 5…K994267 2008K@home Hemodialysis Machine K124035 2008T Hemodialysis Machine K131908 5.4. Device Description This section includes an explanation of how the devices function, the concepts that form the basis… | 2013 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153449 | 2008K2 Hemodialysis Machine | 2016 | 8 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2023 | Class I | Z-0028-2024 | Device Design | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Class I | Z-0031-2024 | Device Design | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Class I | Z-0035-2024 | Device Design | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Class I | Z-0029-2024 | Device Design | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Class I | Z-0030-2024 | Device Design | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Class I | Z-0032-2024 | Device Design | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Class I | Z-0033-2024 | Device Design | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Class I | Z-0034-2024 | Device Design | Potential PCBA leaching from tubing of hemodialysis machines. |
| Dec 21, 2016 | Class II | Z-1026-2017 | Device Design | When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine |
| Dec 21, 2016 | Class II | Z-1027-2017 | Device Design | When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine |
| Dec 21, 2016 | Class II | Z-1029-2017 | Device Design | When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine |
| Dec 21, 2016 | Class II | Z-1028-2017 | Device Design | When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine |
The 5 latest of 12 recalls; the web page lists all.
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 on · ◆ in the 2018 descendants bar of FIG. 18 Class I recalls
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 16 ancestors have a recall of any class.
- Of its descendants, K153449 (Fresenius Medical Care Renal Therapies Group, LLC, 2016) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K994267.
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. 2015, 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?
2008K Hemodialysis Machines: The 2008K Hemodialysis Machine is indicated for acute and chronic dialysis therapy. 2008K@home Hemodialysis Machine: The 2008K@home Hemodialysis Machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home Hemodialysis Machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. bibag System…
Read the full statement (363 words)
2008K Hemodialysis Machines:
The 2008K Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
2008K@home Hemodialysis Machine:
The 2008K@home Hemodialysis Machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home Hemodialysis Machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
bibag System (Optional):
The bibag System is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
Wireless Wetness Detector (Wet Alert):
The Wireless Wetness Detector is indicated for use with the 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.
2008T Hemodialysis Machine:
The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
bibag System (Optional):
The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T Hemodialysis Machine and is 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 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 as stated in the FDA summary.
https://510kreport.com/device/K150708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150708: 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150708
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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