KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II
FDA product code KDI covers "Dialyzer, High Permeability With Or Without Sealed Dialysate System", a Class II medical device regulated under 21 CFR 876.5860. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KDI
- Device Class
- Class II
- Regulation Number
- 876.5860
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252377 | fresenius medical care renal therapies group | NxStage System One with NxView | May 15, 2026 |
| K260533 | nipro medical corporation | ELISIO-H | March 19, 2026 |
| K252459 | fresenius medical care renal therapies group | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | February 10, 2026 |
| K253412 | outset medical | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | January 26, 2026 |
| K253518 | fresenius medical care renal therapies group | FX CorAL 40; FX CorAL 50 | December 18, 2025 |
| K243920 | medica usa | Purema H Hemoconcentrator - Pediatric | September 19, 2025 |
| K250508 | vantive us healthcare | AK 98 Dialysis Machine (955607) | August 1, 2025 |
| K243237 | fresenius medical care renal therapies group | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126) | June 13, 2025 |
| K243505 | fresenius medical care renal therapies group | 5008X Hemodialysis System | May 30, 2025 |
| K242155 | nikkiso co | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | May 15, 2025 |
| K243264 | sorin group italia | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemo | April 25, 2025 |
| K242053 | fresenius medical care renal therapies group | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | March 21, 2025 |
| K243874 | fresenius medical care renal therapies group | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX C | February 28, 2025 |
| K233798 | diality | Moda-flx Hemodialysis System and Cartridge | August 2, 2024 |
| K233557 | deka research and development | HemoCare Hemodialysis System | July 12, 2024 |
| K240394 | fresenius medical care renal therapies group | multiFlux 1000 (F00012408) | May 31, 2024 |
| K232776 | outset medical | Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer | May 3, 2024 |
| K232803 | nxstage medical | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | March 14, 2024 |
| K232171 | tecnoideal america | Purema® H Hemoconcentrator (EtO Sterilized) | February 7, 2024 |
| K231534 | fresenius medical care | 5008X Hemodialysis System | February 2, 2024 |