510(k) · Cleared
Recalled · Class II · 2015Fresenius 2008K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Mar 16, 2000 as substantially equivalent to K921456 (Fresenius USA, Inc., 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994. 4 of the 58 devices in its family, counting itself, have a Class I recall. 56 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 16, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921456 (1994). 56 later devices descend from it, 8 citing it directly. 4 of the 58 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- This deviceK994267 Fresenius 2008KFresenius Medical Care · 2000
- Descendant · cites it directly · 42 of its ownK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- Descendant · 2 generations on · 36 of its ownK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- Descendant · 3 generations on · 19 of its ownK111639 Fresenius 2008T Hemodialysis MachineFresenius Medical Care · 2011 · Recalled
- Descendant · 4 generations on · 18 of its ownK113427 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America · 2011 · Recalled
- Descendant · 5 generations on · 17 of its ownK120505 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 2012 · Recalled
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 56 · See all- K080964Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · cites it directly42descendants
- K093902Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · 2 generations on36descendants
- K111639Fresenius 2008T Hemodialysis MachineFresenius Medical Care · 2011 · 3 generations on19descendants
- K113427Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America · 2011 · 4 generations on18descendants
- K120505Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 2012 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| 0 (this device) | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | — |
| +1 | 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 |
| +3 | K111639 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care | 2011 | 1 |
| +4 | K113427 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2011 | 4 |
| +5 | K120505 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America, Design Cente | 2012 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 1 |
| 2016 | 3 | 0 |
| 2018 | 1 | 1 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 1 |
| 2023 | 3 | 1 |
| 2024 | 5 | 0 |
| 2025 | 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.
4 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 |
|---|---|---|---|
| * | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery SystemSummary page 1…sual Name: Hemodialysis Delivery Equipment Classification Name: Sealed Dialysate Delivery System C. Predicate Device Name: e Fresenius 3008 Dialysate Delivery System (#K921456, 4/20/94) D. Device Description/indications for Use: The indications for use for the Fresenius 2008K are identical to those of t… | 1994 |
What descends from it? (56)
See all 568 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080964 | Fresenius Model 2008T Hemodialysis Machine | 2009 | 42 |
| K070049 | Fresenius 2008K @Home with Wireless Wetness Detector | 2011 | 13 |
| K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine Class I | 2015 | 9 |
| K153449 | 2008K2 Hemodialysis Machine | 2016 | 8 |
| K043436 | Nxstage Dialysate Preparation Module, Model NX0269 | 2005 | 5 |
| K023509 | DBB-05 Hemodialysis Delivery System | 2003 | 4 |
| K133299 | Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand Assembly | 2014 | 0 |
| K050273 | Fresenius Art Hemoadsorption System | 2005 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2015 | Class II | Z-1552-2015 | 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. |
| Feb 20, 2015 | Class II | Z-1551-2015 | 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. |
| Nov 12, 2013 | Class II | Z-0629-2014 | Under Investigation by firm | 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup |
| Nov 20, 2009 | Not classified | Z-2225-2010 | Component design/selection | Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy. |
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 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 18 Class I recalls
- 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
- K233335Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023 · 12 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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.
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 2008K is indicated for acute and chronic dialysis therapy.
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/K994267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994267: Fresenius 2008K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994267
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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