Panels › Gastroenterology, Urology › Product code KDI · Class 2
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation 876.5860
6510(k)s in 12 months (345 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) |
|---|---|---|---|
| Aug 26, 2026 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130. Open, Classified |
KDI | K243237 |
| Jul 8, 2026 | Fresenius 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 |
KDI | K243505 |
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | K042938 |
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | K042938 |
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | K080519 |
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | K041005 |
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | None listed |
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | K212216 |
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | K212216 |
| Dec 17, 2025 | Fresenius Medical Care Holdings, Inc. 5008X CAREsystem +CLiC +CDX; Open, Classified |
KDI | K243505 |
| Dec 11, 2025 | Nipro Medical Corporation Hemodialysis System, Surdial DX
REF: MC+SDX01
Rx Only Open, Classified |
KDI | K182940 |
| Aug 26, 2025 | VANTIVE US HEALTHCARE LLC TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631 Open, Classified |
KDI | K190910 K193482 |
| Aug 26, 2025 | VANTIVE US HEALTHCARE LLC PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 Open, Classified |
KDI | K193482 |
| Aug 26, 2025 | VANTIVE US HEALTHCARE LLC PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 Open, Classified |
KDI | K190910 |
| Jun 18, 2025 | Fresenius 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 |
KDI | K231534 |
| Jan 16, 2025 | Nuwellis 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 |
KDI | K192756 |
| Jan 3, 2025 | Fresenius Medical Care Holdings, Inc. Dialyzer Optiflux 160NRe Open, Classified |
KDI | K162488 |
| Nov 13, 2024 | Baxter Healthcare Corporation Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive. Open, Classified |
KDI | K232467 |
| Oct 3, 2024 | Outset 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 |
KDI | K233335 |
| Sep 11, 2024 | Fresenius 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 |
KDI | None listed |
| Jul 11, 2024 | Fresenius 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 |
KDI | None listed |
| Jul 11, 2024 | Fresenius Medical Care Holdings, Inc. RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Open, Classified |
KDI | None listed |
| Jul 11, 2024 | Fresenius Medical Care Holdings, Inc. RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Open, Classified |
KDI | None listed |
| Jul 11, 2024 | Fresenius 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 |
KDI | None listed |
| Jul 11, 2024 | Fresenius 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 |
KDI | None listed |
| Jul 11, 2024 | Fresenius Medical Care Holdings, Inc. 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Open, Classified |
KDI | None listed |
| Jul 11, 2024 | Fresenius Medical Care Holdings, Inc. 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Open, Classified |
KDI | None listed |
| Jul 11, 2024 | Fresenius Medical Care Holdings, Inc. 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Open, Classified |
KDI | None listed |
| Jun 14, 2024 | Outset 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 |
KDI | K232776 K233335 |
| May 17, 2024 | Fresenius Medical Care Holdings, Inc. 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A Open, Classified |
KDI | K173972 K222952 +1 |
| May 17, 2024 | Fresenius Medical Care Holdings, Inc. 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. Open, Classified |
KDI | K173972 K222952 +1 |
| May 17, 2024 | Fresenius Medical Care Holdings, Inc. 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. Open, Classified |
KDI | K173972 K222952 +1 |
| May 17, 2024 | Fresenius Medical Care Holdings, Inc. 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. Open, Classified |
KDI | K173972 K222952 +1 |
| May 17, 2024 | Fresenius Medical Care Holdings, Inc. Blood Pump Rotor, Model Number: F40015481 Rev A Open, Classified |
KDI | None listed |
| Apr 12, 2024 | Outset Medical, Inc. Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 Open, Classified |
KDI | K233335 |
| Feb 27, 2024 | NxStage 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 |
KDI | K183158 |
| Oct 6, 2023 | Fresenius Medical Care Holdings, Inc. 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR Open, Classified |
KDI | K150708 K173972 +1 |
| Oct 6, 2023 | Fresenius Medical Care Holdings, Inc. 2008T HD SYS. W/O CDX BLUESTAR Open, Classified |
KDI | K150708 K173972 +1 |
| Oct 6, 2023 | Fresenius Medical Care Holdings, Inc. 2008T HD SYS. CDX W/BIBAG BLUESTAR Open, Classified |
KDI | K150708 K173972 +1 |
| Oct 6, 2023 | Fresenius Medical Care Holdings, Inc. 2008T HD SYS. CDX BLUESTAR Open, Classified |
KDI | K150708 K173972 +1 |
| Oct 6, 2023 | Fresenius Medical Care Holdings, Inc. 2008T GEN 2 Bibag without CDX Open, Classified |
KDI | K150708 K173972 +1 |
| Oct 6, 2023 | Fresenius Medical Care Holdings, Inc. 2008T Hemodialysis System w/Bibag Open, Classified |
KDI | K150708 K173972 +1 |
| Oct 6, 2023 | Fresenius Medical Care Holdings, Inc. 2008T Hemodialysis System without CDX Open, Classified |
KDI | K150708 K173972 +1 |
| Oct 6, 2023 | Fresenius Medical Care Holdings, Inc. 2008T Hemodialysis SYS, with CDX Open, Classified |
KDI | K150708 K173972 +1 |
| Dec 22, 2022 | Baxter Healthcare Corporation Revaclear 400 dialyzers.
Indicated for treatment of chronic and acute renal failure by hemodialysis. Open, Classified |
KDI | K130039 |
| Dec 22, 2022 | Baxter Healthcare Corporation Revaclear 400 dialyzers.
Indicated for treatment of chronic and acute renal failure by hemodialysis. Open, Classified |
KDI | K130039 |
| Dec 22, 2022 | Baxter Healthcare Corporation Revaclear 300 dialyzers.
Indicated for treatment of chronic and acute renal failure by hemodialysis. Open, Classified |
KDI | K130039 |
| Dec 22, 2022 | Baxter 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 |
KDI | None listed |
| Dec 22, 2022 | Baxter Healthcare Corporation Revaclear 400 Dialyzer. Product Code: 114746L.
Used to treat chronic and acute renal failure by hemodialysis. Open, Classified |
KDI | K130039 |
| Dec 20, 2022 | Fresenius 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 |
KDI | K173972 |
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