Hemodialysis System For Home Use
Gastroenterology, Urology · 21 CFR 876.5860
To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Recent MDR events
137 adverse event reports on file
- HEMODIALYSIS SYSTEM FOR HOME USEJul 25, 2025InjuryUnknownMW5173346
- 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPOct 24, 2023MalfunctionConcord Manufacturing0002937457-2023-01609
- 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPJul 21, 2022MalfunctionConcord Manufacturing0002937457-2022-01215
- 2008K@HOME HEMODIALYSIS SYSTEMApr 29, 2022InjuryConcord Manufacturing0002937457-2022-00709
- 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAGApr 7, 2022MalfunctionConcord Manufacturing2937457-2022-00594
- HOME HEMO COMBI SET FOR CANADAJan 12, 2022MalfunctionErika De Reynosa, S.a. De C.v.8030665-2022-00043
- HOME HEMO COMBI SET FOR CANADAJan 12, 2022MalfunctionErika De Reynosa, S.a. De C.v.8030665-2022-00042
- 2008K@HOME MACHINEApr 30, 2021MalfunctionConcord Manufacturing2937457-2021-00906
- 2008K@HOME MACHINEApr 30, 2021MalfunctionConcord Manufacturing2937457-2021-00907
- 2008K@HOME HEMODIALYSIS SYSTEMApr 8, 2021MalfunctionConcord Manufacturing2937457-2021-00639
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Fresenius Medical Care Holdings, Inc.TerminatedNov 8, 2013
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Z-0184-2014 · View FDA record ↗ - Fresenius Medical Care Holdings, Inc.TerminatedNov 8, 2013
Combiset Blood Line with BVM for Hemodialysis use
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Z-0185-2014 · View FDA record ↗ - Fresenius Medical Care Holdings, Inc.TerminatedNov 8, 2013
Combiset Blood Line Hemodialysis use
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Z-0186-2014 · View FDA record ↗ - Fresenius Medical Care Holdings, Inc.TerminatedAug 29, 2011
Fresenius 2008K@home
Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k)
Z-3083-2011 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
Fresenius Medical Care Renal Therapies Group, Llc
Waltham, MA, US
Sterigenics Radiation Technologies Canada, Inc
PORT COQUITLAM British Columbia, CA
Isomedix Operations Inc.
GRAND PRAIRIE, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Erika De Reynosa, S.a. De C.v.
CD, REYNOSA Tamaulipas, MX
Erika De Reynosa, S.a. De C.v.
CD, REYNOSA Tamaulipas, MX
510(k) clearances
4 clearances for this product code
- Quanta Dialysis Technologies, Ltd.Nov 1, 2024
K242269 · SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
- Fresenius Medical Care North AmericaJul 3, 2013
K124035 · 2008K@HOME HEMODIALYSIS MACHINE
- Fresenius Medical Care North America, Design CenteJan 17, 2013
K121421 · FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
- Fresenius Medical Care North AmericaFeb 3, 2011
K070049 · FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR