Devices descending from K921456
60 later devices reach Fresenius 3008/FDS-08 Dialysate Delivery System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K040074 | Oneview Interface | Nxstage Medical, Inc. | 2004 | 2 | — |
| +1 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 56 | 5 |
| +2 | K153449 | 2008K2 Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2016 | 8 | 2 |
| +2 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2015 | 9 | Class I |
| +2 | K133299 | Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand Assembly | Fresenius Medical Care, North America - Renal Ther | 2014 | 0 | — |
| +2 | K133547 | Nxstage System One with Nxview | Nxstage Medical, Inc. | 2014 | 1 | 2 |
| +2 | K070049 | Fresenius 2008K @Home with Wireless Wetness Detector | Fresenius Medical Care North America | 2011 | 13 | 7 |
| +2 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 42 | 4 |
| +2 | K050273 | Fresenius Art Hemoadsorption System | Fresenius Medical Care North America | 2005 | 0 | — |
| +2 | K043436 | Nxstage Dialysate Preparation Module, Model NX0269 | Nxstage Medical, Inc. | 2005 | 5 | — |
| +2 | K023509 | DBB-05 Hemodialysis Delivery System | Davita Clinical Research (Trri) | 2003 | 4 | — |
| +3 | K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | 2026 | 0 | — |
| +3 | K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | 7 | Class I |
| +3 | K121421 | Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert) | Fresenius Medical Care North America, Design Cente | 2013 | 12 | 2 |
| +3 | K093362 | 2008 Hemodialysis Sorbent System | Renal Solutions, Inc. | 2010 | 1 | — |
| +3 | K093964 | Venofer Pump | Renal Solutions, Inc. | 2010 | 2 | — |
| +3 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 36 | 2 |
| +3 | K091978 | DBB-06 Hemodialysis Delivery System | Nikkiso CO., LTD. | 2010 | 2 | 1 |
| +3 | K081043 | Leak Detection Sensor and Tray Accessory Kit | Nxstage Medical, Inc. | 2008 | 0 | — |
| +3 | K061519 | Modification to DBB-05 Hemodialysis Delivery System | Nikkiso CO., LTD. | 2007 | 3 | — |
| +3 | K060296 | Nxstage Dialysate Preparation Module | Nxstage Medical, Inc. | 2006 | 3 | — |
| +4 | K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 4 | 4 |
| +4 | K222952 | 2008T BlueStar Hemodailysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | 3 | Class I |
| +4 | K152938 | DBB-06 Hemodialysis Delivery System | Nikkiso CO., LTD. | 2016 | 1 | 1 |
| +4 | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | 11 | — |
| +4 | K123835 | 2008 Hemodialysis Sorbent System | Renal Solutions, Inc. | 2013 | 0 | — |
| +4 | K111639 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care | 2011 | 19 | 1 |
| +4 | K103564 | Venofer Pump | Renal Solutions, Inc. | 2011 | 1 | — |
| +4 | K101715 | Fresenius 2008T Hemodialysis Machine Model 190573 | Fresenius Medical Care North America, Design Cente | 2010 | 15 | 1 |
| +4 | K080919 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2008 | 2 | 1 |
| +5 | K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 0 | 1 |
| +5 | K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 1 | 6 |
| +5 | K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | Nikkiso CO., LTD. | 2025 | 0 | — |
| +5 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 2 | 1 |
| +5 | K121497 | Venofer Pump | Renal Solutions, Inc. | 2012 | 0 | 1 |
| +5 | K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 14 | 3 |
| +5 | K113427 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2011 | 18 | 4 |
| +5 | K111174 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2011 | 1 | 9 |
| +6 | K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 0 | — |
| +6 | K140571 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2014 | 0 | 9 |
| +6 | K121341 | Fresenius 2008T Hemodialysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 13 | 5 |
| +6 | K120505 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America, Design Cente | 2012 | 17 | 4 |
| +7 | K140866 | Tablo Console | Home Dialysis Plus | 2014 | 16 | — |
| +7 | K131908 | 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic) | Fresenius Medical Care Renal Therapies Group, LLC | 2013 | 10 | — |
| +8 | K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set | Quanta Dialysis Technologies, Ltd. | 2020 | 3 | — |
| +8 | K150880 | Tablo Console with Wireless Capability | Outset Medical | 2015 | 11 | — |
| +9 | K210661 | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset | Quanta Dialysis Technologies, Ltd. | 2021 | 2 | — |
| +9 | K160881 | Tablo Console | Outset Medical, Inc. | 2016 | 10 | — |
| +10 | K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set… | Quanta Dialysis Technologies, Ltd. | 2024 | 0 | — |
| +10 | K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set | Quanta Dialysis Technologies, Ltd. | 2022 | 0 | — |
| +10 | K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020 | 7 | 1 |
| +10 | K190793 | Tablo Hemodialysis System, Tablo Cartridge | Outset Medical, Inc. | 2019 | 2 | 2 |
| +11 | K211370 | Tablo Hemodialysis System | Outset Medical, Inc. | 2022 | 6 | 1 |
| +11 | K210782 | Tablo Cartridge | Outset Medical, Inc. | 2021 | 1 | — |
| +12 | K233798 | Moda-flx Hemodialysis System and Cartridge | Diality, Inc. | 2024 | 0 | — |
| +12 | K233557 | HemoCare Hemodialysis System | Deka Research and Development | 2024 | 0 | — |
| +12 | K223248 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023 | 4 | — |
| +13 | K232776 | Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer | Outset Medical, Inc. | 2024 | 0 | 1 |
| +13 | K233335 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023 | 1 | Class I |
| +14 | K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | 2026 | 0 | — |