510(k) · Cleared
Recalled · Class II · 2017Fresenius 2008T Hemodialysis Machine
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 21, 2011 as substantially equivalent to K111639 (Fresenius Medical Care, 2011) after a 30-day review. Its family tree reaches back 5 generations to 1994. 1 of the 24 devices in its family, counting itself, has a Class I recall. 18 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 21, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921456 (1994). 18 later devices descend from it, 1 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 4 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 3 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 2 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 1 generation backK111639 Fresenius 2008T Hemodialysis MachineFresenius Medical Care · 2011 · Recalled
- This deviceK113427 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America · 2011
- Descendant · cites it directly · 17 of its ownK120505 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 2012 · Recalled
- Descendant · 2 generations on · 16 of its ownK140866 Tablo ConsoleHome Dialysis Plus · 2014
- Descendant · 3 generations on · 11 of its ownK150880 Tablo Console with Wireless CapabilityOutset Medical · 2015
- Descendant · 4 generations on · 10 of its ownK160881 Tablo ConsoleOutset Medical, Inc. · 2016
- Descendant · 5 generations on · 7 of its ownK200741 Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233335 Tablo® Hemodialysis System8 generations on · 2023
Most influential descendants
Showing 5 of 18 · See all- K120505Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 2012 · cites it directly17descendants
- K140866Tablo ConsoleHome Dialysis Plus · 2014 · 2 generations on16descendants
- K150880Tablo Console with Wireless CapabilityOutset Medical · 2015 · 3 generations on11descendants
- K160881Tablo ConsoleOutset Medical, Inc. · 2016 · 4 generations on10descendants
- K200741Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −4 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −3 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −2 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −1 | K111639 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care | 2011 | 1 |
| 0 (this device) | K113427 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2011 | — |
| +1 | K120505 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America, Design Cente | 2012 | 4 |
| +2 | K140866 | Tablo Console | Home Dialysis Plus | 2014 | — |
| +3 | K150880 | Tablo Console with Wireless Capability | Outset Medical | 2015 | — |
| +4 | K160881 | Tablo Console | Outset Medical, Inc. | 2016 | — |
| +5 | K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 1 |
| 2024 | 4 | 0 |
| 2026 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K111639 | Fresenius 2008T Hemodialysis MachineSummary page 1…Classification Name: Class 11per § 876.5860 C. Legally Marketed Predicate Device (Unmodified Device) Fresenius 2008T Hemodialysis Machine (K111639). D. Device Description The Fresenius 2008T Hemodialysis Machine (K111639) is indicated for acute and chroni… | 2011 |
| † | K080964 | Fresenius Model 2008T Hemodialysis Machine | 2009 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120505 | Fresenius 2008T Hemodialysis Machine | 2012 | 17 |
Has anything in its family been recalled? (1 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. |
| May 24, 2013 | Class II | Z-1693-2013 | Nonconforming Material/Component | Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber) |
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.
- K233335Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023 · 8 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 5 ancestors have a recall of any class.
- Of its descendants, K120505 (Fresenius Medical Care North America, Design Cente, 2012) has gone furthest, with 17 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. 2011, 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?
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113427: Fresenius 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/K113427
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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