ClearanceBrief
510(k) K150708 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine

ApplicantFresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US
DecisionSubstantially Equivalent, Dec 10, 2015
ReceivedMar 19, 2015
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K150708

DateFirm and productCodeLinked 510(k)
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 21, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008T Series Hemodialysis System
Terminated		 KDINone listed
Dec 21, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008K Series : Hemodialysis System
Terminated		 KDINone listed
Dec 21, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008K2 Series : Hemodialysis System
Terminated		 KDINone listed
Dec 21, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008K@home Series : Hemodialysis System
Terminated		 KDINone listed

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