ClearanceBrief
510(k) K173972 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

2008T BlueStar Hemodialysis Machine

ApplicantFresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US
DecisionSubstantially Equivalent, May 10, 2018
ReceivedDec 29, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K173972

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
Dec 20, 2022Fresenius Medical Care Holdings, Inc.
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 200
Open, Classified		 KDINone listed
Mar 12, 2020Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 19
Open, Classified		 KDINone listed
Mar 12, 2020Fresenius Medical Care Holdings, Inc.
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2
Open, Classified		 KDINone listed
Jan 29, 2020Fresenius Medical Care Holdings, Inc.
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery E
Terminated		 KDINone listed
Apr 3, 2019Fresenius Medical Care Renal Therapies Group, LLC
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare fa
Terminated		 KDINone listed
Jul 13, 2018Fresenius Medical Care Renal Therapies Group, LLC
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
Terminated		 KDINone listed
Jul 13, 2018Fresenius Medical Care Renal Therapies Group, LLC
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
Terminated		 KDINone listed

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