Home › Device types › KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA product code KDI · Class 2 · Gastroenterology, Urology
0
Registered devices
43,984
Adverse events
217
Recalls
345
510(k) clearances
Devices with this code
therMaxTherMax Blood Warmer — BAXTER HEALTHCARE CORPORATIONOptiflux® — Fresenius Medical Care Holdings, Inc.Revaclear — Baxter Healthcare SAAquaFlexFlow UF 500 Plus — Nuwellis Inc.Optiflux® — Fresenius Medical Care Holdings, Inc.NXSTAGE SYSTEM ONE — NXSTAGE MEDICAL, INC.FX CorAL — Fresenius Medical Care AGREXEED — ASAHIKASEI MEDICAL MT K.K.SC+ Hemodialysis System — QUANTA DIALYSIS TECHNOLOGIES LIMITEDBlood Pressure Cuff — Fresenius Medical Care AGModa-flx Hemodialysis System — Diality IncPRISMAFLEX SET — Vantive Health GmbH2008® Series Hemodialysis Machines — Fresenius Usa, Inc.Diacap® — B.Braun Avitum AGBlood pressure cuff for SURDIAL DX Hemodialysis System — NIPRO MEDICAL CORPORATIONxevonta — B.Braun Avitum AGOptiflux® — Fresenius Medical Care Holdings, Inc.Fresenius — Fresenius Usa, Inc.REVACLEAR — Gambro Dialysatoren GmbHNXView Touch Monitor — NXSTAGE MEDICAL, INC.B.BRAUN — B.Braun Avitum AGEXPRESS FLUID WARMER — NXSTAGE MEDICAL, INC.Dialog+® — B.Braun Avitum AGNXSTAGE CARTRIDGE EXPRESS — NXSTAGE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-30 | Fresenius Medical Care Renal Therapies Group, LLC | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T Blue |
| 2026-05-11 | Fresenius Medical Care Holdings, Inc. | Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsyst |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2025-10-27 | Nipro Medical Corporation | Screw may loosen or fallout of Hemodialysis system |
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