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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 2026 | K261203 | multiFiltratePRO System Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Jul 24, 2026 | K261267 | Careflux H60;Careflux H70;Careflux V500 Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| May 15, 2026 | K252377 | NxStage System One with NxView Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Mar 19, 2026 | K260533 | ELISIO-H Nipro Medical Corporation | KDI |
| Feb 10, 2026 | K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Jan 26, 2026 | K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) Outset Medical, Inc. | KDI |
| Dec 18, 2025 | K253518 | FX CorAL 40; FX CorAL 50 Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Sep 19, 2025 | K243920 | Purema H Hemoconcentrator - Pediatric Medica USA, Inc. | KDI |
| Aug 1, 2025 | K250508 | AK 98 Dialysis Machine (955607) Vantive US Healthcare, LLC | KDI |
| Jun 13, 2025 | K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128 Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| May 30, 2025 | K243505 | 5008X Hemodialysis System Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| May 15, 2025 | K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) NIKKISO CO., LTD., JP | KDI |
| Apr 25, 2025 | K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) Sorin Group Italia S.R.L., IT | KDI |
| Mar 21, 2025 | K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Feb 28, 2025 | K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F000 Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Aug 2, 2024 | K233798 | Moda-flx Hemodialysis System and Cartridge Diality, Inc. | KDI |
| Jul 12, 2024 | K233557 | HemoCare Hemodialysis System Deka Research and Development | KDI |
| May 31, 2024 | K240394 | multiFlux 1000 (F00012408) Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| May 3, 2024 | K232776 | Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer Outset Medical, Inc. | KDI |
| Mar 14, 2024 | K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) Nxstage Medical, Inc. | KDI |
| Feb 7, 2024 | K232171 | Purema® H Hemoconcentrator (EtO Sterilized) Tecnoideal America | KDI |
| Feb 2, 2024 | K231534 | 5008X Hemodialysis System Fresenius Medical Care | KDI |
| Dec 6, 2023 | K231125 | 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Dec 5, 2023 | K233335 | Tablo® Hemodialysis System Outset Medical, Inc. | KDI |
| Sep 14, 2023 | K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine Baxter Healthcare Corporation | KDI |
| Aug 11, 2023 | K230632 | VersiHD with GuideMe software Nxstage Medical, Inc. | KDI |
| Jun 21, 2023 | K223248 | Tablo® Hemodialysis System Outset Medical, Inc. | KDI |
| Jun 14, 2023 | K231406 | ClearumTM HS Bellco Srl, IT | KDI |
| May 11, 2023 | K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Dec 16, 2022 | K220281 | multiFiltratePRO System Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Nov 10, 2022 | K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set Quanta Dialysis Technologies, Ltd., GB | KDI |
| Oct 27, 2022 | K222952 | 2008T BlueStar Hemodailysis Machine Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Jul 29, 2022 | K211370 | Tablo Hemodialysis System Outset Medical, Inc. | KDI |
| May 13, 2022 | K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter Nephros | KDI |
| Apr 1, 2022 | K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set Baxter Healthcare Corporation | KDI |
| Jan 24, 2022 | K213639 | Revaclear 500, Revaclear 400, Revaclear 300 Baxter Healthcare Corporation | KDI |
| Aug 12, 2021 | K210661 | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset Quanta Dialysis Technologies, Ltd., GB | KDI |
| Mar 10, 2021 | K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory Baxter Healthcare Corportation | KDI |
| Dec 28, 2020 | K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Dec 23, 2020 | K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set Quanta Dialysis Technologies, Ltd., GB | KDI |
| Oct 8, 2020 | K193542 | Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 Bellco Srl, IT | KDI |
| Sep 21, 2020 | K192707 | Optiflux F180NR Dialyzer Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Aug 28, 2020 | K193005 | DIMI RRT System Dialco Medical, Inc., CA | KDI |
| Jul 9, 2020 | K192928 | Optiflux Enexa F500 Dialyzer Fresenius Medical Care Reanal Therapies Group, LLC | KDI |
| Mar 31, 2020 | K200741 | Tablo Hemodialysis System Outset Medical, Inc. | KDI |
| Mar 13, 2020 | K193482 | PrisMax System Version 3 Baxter Healthcare Corporation | KDI |
| Feb 24, 2020 | K192756 | Aquadex FlexFlow System 2.0 Chf Solutions, Inc. | KDI |
| Dec 12, 2019 | K190793 | Tablo Hemodialysis System, Tablo Cartridge Outset Medical, Inc. | KDI |
| Aug 9, 2019 | K183158 | NxStage Cartridge Express with Speedswap Nxstage Medical, Inc. | KDI |
| Jul 25, 2019 | K190910 | PrisMax System Version 2 Baxter Healthcare Corp | KDI |
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