ClearanceBrief
510(k) K222952 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

2008T BlueStar Hemodailysis Machine

ApplicantFresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US
DecisionSubstantially Equivalent, Oct 27, 2022
ReceivedSep 27, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K222952

DateFirm and productCodeLinked 510(k)
May 17, 2024Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Open, Classified		 KDINone listed
May 17, 2024Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Open, Classified		 KDINone listed
May 17, 2024Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Open, Classified		 KDINone listed
May 17, 2024Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Open, Classified		 KDINone listed
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis SYS, with CDX
Open, Classified		 KDINone listed
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis System without CDX
Open, Classified		 KDINone listed
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis System w/Bibag
Open, Classified		 KDINone listed
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T GEN 2 Bibag without CDX
Open, Classified		 KDINone listed
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. CDX BLUESTAR
Open, Classified		 KDINone listed
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. CDX W/BIBAG BLUESTAR
Open, Classified		 KDINone listed
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX BLUESTAR
Open, Classified		 KDINone listed
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Open, Classified		 KDINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.