KDI
- Product code
- KDI
- Device name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5860
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 24
- Summaries archived here
- 22 (direct download)
- 510(k) clearances (all years, FDA)
- 345 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (24)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261267 | 2026-07-24 | Fresenius Medical Care Renal Therapies… | Careflux H60;Careflux H70;Careflux V500 | |
| K252377 | 2026-05-15 | Fresenius Medical Care Renal Therapies… | NxStage System One with NxView | |
| K260533 | 2026-03-19 | Nipro Medical Corporation | ELISIO-H | FDA |
| K252459 | 2026-02-10 | Fresenius Medical Care Renal Therapies… | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | |
| K253412 | 2026-01-26 | Outset Medical, Inc. | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | |
| K253518 | 2025-12-18 | Fresenius Medical Care Renal Therapies… | FX CorAL 40; FX CorAL 50 | |
| K243920 | 2025-09-19 | Medica USA, Inc. | Purema H Hemoconcentrator - Pediatric | |
| K250508 | 2025-08-01 | Vantive US Healthcare, LLC | AK 98 Dialysis Machine (955607) | FDA |
| K243237 | 2025-06-13 | Fresenius Medical Care Renal Therapies… | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. C… | |
| K243505 | 2025-05-30 | Fresenius Medical Care Renal Therapies… | 5008X Hemodialysis System | |
| K242155 | 2025-05-15 | NIKKISO CO., LTD. | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | |
| K243264 | 2025-04-25 | Sorin Group Italia S.R.L. | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconce… | |
| K242053 | 2025-03-21 | Fresenius Medical Care Renal Therapies… | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | |
| K243874 | 2025-02-28 | Fresenius Medical Care Renal Therapies… | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX… | |
| K233798 | 2024-08-02 | Diality, Inc. | Moda-flx Hemodialysis System and Cartridge | |
| K233557 | 2024-07-12 | Deka Research and Development | HemoCare Hemodialysis System | |
| K240394 | 2024-05-31 | Fresenius Medical Care Renal Therapies… | multiFlux 1000 (F00012408) | |
| K232776 | 2024-05-03 | Outset Medical, Inc. | Tablo® Hemodialysis System; TabloCart with Prefiltr… | |
| K232803 | 2024-03-14 | Nxstage Medical, Inc. | NxStage System One with Cartridge Express (CAR-170-E… | |
| K232171 | 2024-02-07 | Tecnoideal America | Purema® H Hemoconcentrator (EtO Sterilized) | |
| K231534 | 2024-02-02 | Fresenius Medical Care | 5008X Hemodialysis System | |
| K231125 | 2023-12-06 | Fresenius Medical Care Renal Therapies… | 2008T BlueStar Hemodialysis Machine | |
| K233335 | 2023-12-05 | Outset Medical, Inc. | Tablo® Hemodialysis System | |
| K232467 | 2023-09-14 | Baxter Healthcare Corporation | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine |
Official FDA classification page: KDI
Classification and pathway per current FDA publications. Data from openFDA (CC0).