ClearanceBrief
Panels › Gastroenterology, Urology › Product code KDI · Class 2

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Regulation 876.5860

7510(k)s in 12 months (346 all time)
11recalls in 12 months (217 all time)
192recalls that name a 510(k)
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Top companies in KDI

DateFirm and productCodeLinked 510(k)
Aug 26, 2026Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Open, Classified
KDIK243237
Jul 8, 2026Fresenius Medical Care Holdings, Inc.
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard B
Open, Classified
KDIK243505
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified
KDIK042938
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified
KDIK042938
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified
KDIK080519
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified
KDIK041005
Feb 2, 2026VANTIVE US HEALTHCARE LLC
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified
KDINone listed
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified
KDIK212216
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified
KDIK212216
Dec 17, 2025Fresenius Medical Care Holdings, Inc.
5008X CAREsystem +CLiC +CDX;
Open, Classified
KDIK243505
Dec 11, 2025Nipro Medical Corporation
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
Open, Classified
KDIK182940
Aug 26, 2025VANTIVE US HEALTHCARE LLC
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Open, Classified
KDIK190910
K193482
Aug 26, 2025VANTIVE US HEALTHCARE LLC
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Open, Classified
KDIK193482
Aug 26, 2025VANTIVE US HEALTHCARE LLC
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Open, Classified
KDIK190910
Jun 18, 2025Fresenius Medical Care Holdings, Inc.
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number:
Open, Classified
KDIK231534
Jan 16, 2025Nuwellis Inc
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
Completed
KDIK192756
Jan 3, 2025Fresenius Medical Care Holdings, Inc.
Dialyzer Optiflux 160NRe
Open, Classified
KDIK162488
Nov 13, 2024Baxter Healthcare Corporation
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Open, Classified
KDIK232467
Oct 3, 2024Outset Medical, Inc.
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or witho
Open, Classified
KDIK233335
Sep 11, 2024Fresenius Medical Care Holdings, Inc.
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 19
Open, Classified
KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified
KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified
KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified
KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified
KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified
KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified
KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified
KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified
KDINone listed
Jun 14, 2024Outset Medical, Inc.
TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodial
Open, Classified
KDIK232776
K233335
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
KDIK173972
K222952 +1
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
KDIK173972
K222952 +1
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
KDIK173972
K222952 +1
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
KDIK173972
K222952 +1
May 17, 2024Fresenius Medical Care Holdings, Inc.
Blood Pump Rotor, Model Number: F40015481 Rev A
Open, Classified
KDINone listed
Apr 12, 2024Outset Medical, Inc.
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Open, Classified
KDIK233335
Feb 27, 2024NxStage MDS Corporation
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic rena
Open, Classified
KDIK183158
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Open, Classified
KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX BLUESTAR
Open, Classified
KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. CDX W/BIBAG BLUESTAR
Open, Classified
KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. CDX BLUESTAR
Open, Classified
KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T GEN 2 Bibag without CDX
Open, Classified
KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis System w/Bibag
Open, Classified
KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis System without CDX
Open, Classified
KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis SYS, with CDX
Open, Classified
KDIK150708
K173972 +1
Dec 22, 2022Baxter Healthcare Corporation
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Open, Classified
KDIK130039
Dec 22, 2022Baxter Healthcare Corporation
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Open, Classified
KDIK130039
Dec 22, 2022Baxter Healthcare Corporation
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Open, Classified
KDIK130039
Dec 22, 2022Baxter Healthcare Corporation
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
Open, Classified
KDINone listed
Dec 22, 2022Baxter Healthcare Corporation
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Open, Classified
KDIK130039
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
KDIK173972

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