510(k) · Cleared
Recalled · Class II · 2017Fresenius 2008T Hemodialysis Machine with Bibag System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Dec 6, 2012 as substantially equivalent to K120017 (Fresenius Medical Care North America, 2012) after a 217-day review. Its family tree reaches back 6 generations to 1994. 3 of the 23 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 6, 2012
- Review
- 217 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921456 (1994). 9 ancestors in all, the oldest K873155 (1987). 13 later devices descend from it, 3 citing it directly. 3 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 5 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 4 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 3 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 2 generations backK101715 Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · Recalled
- 1 generation backK120017 Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- This deviceK121341 Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012
- Descendant · cites it directly · 11 of its ownK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
- Descendant · cites it directly · 10 of its ownK131908 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC · 2013
- Descendant · 2 generations on · 9 of its ownK150708 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T…Fresenius Medical Care Renal Therapies Group, LLC · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 8 of its ownK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- Descendant · 4 generations on · 7 of its ownK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013 · cites it directly11descendants
- K1319082008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC · 2013 · cites it directly10descendants
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 2 generations on9descendants
- K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · 3 generations on8descendants
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −5 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −4 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −3 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −2 | K101715 | Fresenius 2008T Hemodialysis Machine Model 190573 | Fresenius Medical Care North America, Design Cente | 2010 | 1 |
| −1 | K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 3 |
| 0 (this device) | K121341 | Fresenius 2008T Hemodialysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | — |
| +1 | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | — |
| +1 | K131908 | 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic) | Fresenius Medical Care Renal Therapies Group, LLC | 2013 | — |
| +2 | 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 |
| +4 | K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 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? (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 |
|---|---|---|---|
| * | K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag SystemSummary page 1…ation Panel: 78KD/Gastroenterology/Urology Panel C. Legally Marketed Predicate Device (unmodified device) Fresenius 2008T Hemodialysis Machine with bibag System (K120017). Vol. I… | 2012 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2017 | Class II | Z-0829-2018 | Software Design Change | While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software… |
| Mar 10, 2016 | Class II | Z-1325-2016 | Device Design | Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12) |
| Feb 20, 2015 | Class II | Z-1550-2015 | Software design | The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen. |
| Dec 16, 2014 | Class II | Z-1015-2015 | Under Investigation by firm | Unqualified power assemblies shipped to customers. |
| Apr 25, 2014 | Class II | Z-1618-2014 | Device Design | 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump |
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.
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 18 Class I recalls
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 18 Class I recalls
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 9 ancestors have a recall of any class.
- Of its descendants, K124035 (Fresenius Medical Care North America, 2013) has gone furthest, with 11 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 Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121341: Fresenius 2008T Hemodialysis Machine with Bibag System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121341
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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