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)
Top companies in KDI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2022 | Baxter Healthcare Corporation Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies. Open, Classified |
KDI | K042938 |
| Oct 12, 2022 | Baxter Healthcare Corporation Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies. Open, Classified |
KDI | K212216 |
| Oct 12, 2022 | Baxter Healthcare Corporation Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies. Open, Classified |
KDI | K042938 |
| Oct 12, 2022 | Baxter Healthcare Corporation Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies. Open, Classified |
KDI | K080519 |
| Oct 12, 2022 | Baxter Healthcare Corporation Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies. Open, Classified |
KDI | K041005 |
| May 4, 2022 | Fresenius Medical Care Holdings, Inc. Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E Terminated |
KDI | K162488 |
| Mar 15, 2022 | Baxter Healthcare Corporation PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 Open, Classified |
KDI | None listed |
| Mar 15, 2022 | Baxter Healthcare Corporation PrisMax System, Product Code 955724 Open, Classified |
KDI | None listed |
| Mar 15, 2022 | Baxter Healthcare Corporation PrisMax System, Product Code 955626 Open, Classified |
KDI | None listed |
| Jan 28, 2022 | B Braun Medical Inc Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts fo Terminated |
KDI | K083460 |
| Jan 28, 2022 | B Braun Medical Inc Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts fo Terminated |
KDI | K083460 |
| Jan 20, 2022 | Outset Medical, Inc. Outset Tablo Console
Model Number: PN-0003000
Model Number: PN-0006000 Open, Classified |
KDI | K190793 K200741 |
| Nov 24, 2021 | Nikkiso Ltd - Shizuoka Plant DBB-06 Hemodialysis Delivery System Open, Classified |
KDI | K091978 K152938 |
| Sep 29, 2021 | Baxter Healthcare Corporation Hemodialysis Delivery System, Software Version 2.x. Open, Classified |
KDI | K190910 |
| Jul 22, 2021 | Baxter Healthcare Corporation Baxter prismaflex, HF 1000 PAES membrane, REF 107140
Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies. Terminated |
KDI | K042938 |
| Jul 22, 2021 | Baxter Healthcare Corporation Baxter PrismaFlex, REF numbers:
a) 106696 (M 60 SET)
b) 106697 (M 100 SET)
Expansion:
c) 107144 (TPE2000 SET)
d) 115307 (M 150 SET)
e) 115309 (ST 100 SET)
f) 955467 (M 150 SET)
g) 955468 (ST 100 S Terminated |
KDI | K041005 |
| Jan 28, 2021 | Baxter Healthcare Corporation Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT). Terminated |
KDI | None listed |
| Jan 28, 2021 | Baxter Healthcare Corporation Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). Terminated |
KDI | K131516 |
| Jan 28, 2021 | Baxter Healthcare Corporation Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). Terminated |
KDI | K110823 |
| Jan 28, 2021 | Baxter Healthcare Corporation Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). Terminated |
KDI | K072093 |
| Jan 7, 2021 | Baxter Healthcare Corporation The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers:
a) 955626
b) 955558
c) 955701
PrisMax V2 Preventive Maint Terminated |
KDI | K190910 |
| Apr 7, 2020 | Baxter Healthcare Corporation Prismaflex Control Unit Terminated |
KDI | K131516 |
| Mar 12, 2020 | Fresenius 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 |
KDI | K173972 |
| Mar 12, 2020 | Fresenius 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 |
KDI | K173972 |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | K072093 K110823 |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | K072093 K110823 |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | K072093 K110823 |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | K072093 K110823 |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | K072093 K110823 |
| Feb 6, 2020 | Baxter Healthcare Corporation Prismaflex System, Prismaflex Control Unit Terminated |
KDI | K072093 K110823 |
| Jan 29, 2020 | Fresenius 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 |
KDI | K153449 K173972 |
| Nov 15, 2019 | Baxter Healthcare Corporation Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L Terminated |
KDI | K130039 |
| Oct 30, 2019 | Baxter Healthcare Corporation TherMax Blood Warmer Unit Terminated |
KDI | K190910 |
| Oct 4, 2019 | Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Open, Classified |
KDI | K072093 |
| Oct 4, 2019 | Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Open, Classified |
KDI | K072093 |
| Oct 4, 2019 | Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Open, Classified |
KDI | K072093 |
| Oct 4, 2019 | Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Open, Classified |
KDI | K072093 |
| Oct 4, 2019 | Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Open, Classified |
KDI | K072093 |
| May 31, 2019 | Baxter Healthcare Corporation REVACLEAR 400 Dialyzer, Product Code 114746L
Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis. Terminated |
KDI | K130039 |
| May 31, 2019 | Baxter Healthcare Corporation REVACLEAR 300 Dialyzer, Product Code 114745L
Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis. Terminated |
KDI | K130039 |
| Apr 3, 2019 | Fresenius 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 |
KDI | K173972 |
| Nov 5, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E Terminated |
KDI | K152367 K162488 |
| Jul 13, 2018 | Fresenius 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 |
KDI | K173972 |
| Jul 13, 2018 | Fresenius 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 |
KDI | K173972 |
| Jun 11, 2018 | NxStage Medical, Inc. NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A)
Product Usage:
The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prio Terminated |
KDI | K071263 |
| Apr 24, 2018 | Baxter Healthcare Corporation Prismaflex 7.20 US, Product Code 955542
Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute Terminated |
KDI | K131516 |
| Apr 24, 2018 | Baxter Healthcare Corporation Prismaflex 7.XX US, Product Code 115269
Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute Terminated |
KDI | K131516 |
| Apr 24, 2018 | Baxter Healthcare Corporation Prismaflex 7.XX ROW, Product Code 114870
Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acut Terminated |
KDI | None listed |
| Apr 24, 2018 | Baxter Healthcare Corporation Prismaflex 5.10 US, Product Code 113081
Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute Terminated |
KDI | K110823 |
| Apr 24, 2018 | Baxter Healthcare Corporation Prismaflex System, Product Code 107493
Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute Terminated |
KDI | K072093 |
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