Devices descending from K900105
44 later devices reach Cobe Spectra Blood Component Separator Therapeutic through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K111702 | Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe | Fenwal, Inc. | 2012 | 2 | 1 |
| +1 | K973322 | Diapact CRRT | B.Braun Medical, Inc. | 1998 | 39 | — |
| +1 | K953681 | Haemonetics Therapeutic Plasma Exchange Set | Haemonetics Corp. | 1996 | 0 | — |
| +2 | K141019 | Amicus Separator System/ Amicus Seperator System;Refurbished | Fenwal, Inc. | 2014 | 1 | — |
| +2 | K070320 | Edwards Aquarius Hemofiltration System, Model Abm 01 | Edwards Lifesciences Services GmbH | 2007 | 1 | 1 |
| +2 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | 29 | — |
| +2 | K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corp | 2002 | 8 | 3 |
| +3 | K162462 | AMICUS Separator System, AMICUS Separator System; Refurbished | Fresenius Kabi USA,Llc | 2016 | 0 | — |
| +3 | K090682 | Edwards Aquarius System, Model GE-F098-00 | Edwards Lifesciences Services GmbH | 2009 | 0 | — |
| +3 | K063293 | Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards… | Edwards Lifesciences Services GmbH | 2007 | 0 | — |
| +3 | K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | Gambro Renal Products | 2004 | 4 | 7 |
| +3 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | 28 | — |
| +4 | K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | Baxter Healthcare Corporation | 2022 | 0 | 3 |
| +4 | K080519 | Prismaflex M150 Set | Gambro Renal Products, Inc. | 2008 | 1 | 3 |
| +4 | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | 27 | 2 |
| +4 | K042938 | Gambro Prismaflex HF1000 and HF1400 Sets | Gambro Renal Products | 2005 | 1 | 7 |
| +5 | K220281 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | 0 | — |
| +5 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | 26 | — |
| +6 | K160558 | Rapido Hollow-Fibre Dialyzers | Bellco Srl | 2016 | 0 | — |
| +6 | K131050 | Nxstage 1.6M2 Dialyzer | Nxstage Medical, Inc. | 2013 | 0 | — |
| +6 | K122952 | Nipro Pureflux-L Hemodialyzer | Nipro Medical Corporation | 2013 | 0 | — |
| +6 | K122343 | Pureflux-H Hemodialyzer | Nipro Medical Corporation | 2013 | 0 | — |
| +6 | K083778 | Xenium XPH, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2009 | 20 | — |
| +6 | K082414 | Optiflux F250NR, Model 0500325E | Fresenius Medical Care North America | 2008 | 16 | 3 |
| +7 | K123262 | Optiflux Ultra Dialyzer | Fresenius Medical Care North America | 2014 | 13 | — |
| +7 | K131381 | Elisio-H Hemodialyzer | Nipro Medical Corporation | 2013 | 2 | — |
| +7 | K122347 | Elisio-H and Elisio-M Hemodialyzers | Nipro Medical Corporation | 2013 | 5 | — |
| +7 | K093120 | Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170 | Baxter Healthcare Corporation - Renal Division | 2010 | 6 | — |
| +8 | K152367 | Optiflux dialyzer | Fresenius Medical Care North America | 2015 | 12 | 1 |
| +8 | K140191 | Elisio-H Hemodialyzer | Nipro Medical Corporation | 2014 | 1 | — |
| +8 | K131935 | Elisio-H Hemodialyzer, Elisio-M Hemodialyzer | Nipro Medical Corporation | 2013 | 3 | — |
| +9 | K260533 | Elisio™-H | Nipro Medical Corporation | 2026 | 0 | — |
| +9 | K192707 | Optiflux F180NR Dialyzer | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | 0 | — |
| +9 | K192928 | Optiflux Enexa F500 Dialyzer | Fresenius Medical Care Reanal Therapies Group, LLC | 2020 | 0 | — |
| +9 | K162488 | Optiflux dialyzer | Fresenius Medical Care North America | 2017 | 9 | 4 |
| +9 | K160444 | FB-U Hemodialyzer | Nipro Medical Corporation | 2017 | 0 | — |
| +10 | K261267 | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | 2026 | 0 | — |
| +10 | K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX… | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 6 | — |
| +10 | K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | 1 | — |
| +11 | K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 1 | — |
| +11 | K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 2 | — |
| +11 | K240394 | multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | 1 | — |
| +12 | K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | 2026 | 0 | — |
| +12 | K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 0 | — |