KDI
- 产品代码
- KDI
- 器械名称
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.5860
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属生命支持/维持器械
- 该代码近三年的 510(k)
- 24 件
- 其中 Summary 已存档
- 22 份，可直接下载
- FDA 历史累计 510(k)
- 345 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（24 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| 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 |
FDA 官方分类页： KDI
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。