Home › Device types › KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA product code KDI · Class 2 · Gastroenterology, Urology
334
Registered devices
43,552
Adverse events
217
Recalls
345
510(k) clearances
Devices with this code
Acid connector cpl 10L jug — Fresenius Medical Care Renal Therapies Group, LLCNXSTAGE CARTRIDGE EXPRESS — NXSTAGE MEDICAL, INC.CLEARUM HS — BELLCO SRLPRISMAFLEX SET — GAMBRO INDUSTRIES2008T BlueStar Hemodialysis Machine — Fresenius Medical Care Holdings, Inc.Aquadex SmartFlow Console — Nuwellis Inc.POLYFLUX — Gambro Dialysatoren GmbHNA — Maquet Cardiopulmonary AGVersiHD — NXSTAGE MEDICAL, INC.NXSTAGE CARTRIDGE EXPRESS — NXSTAGE MEDICAL, INC.NXSTAGE SYSTEM ONE — NXSTAGE MEDICAL, INC.CAPIOX® HEMOCONCENTRATOR — TERUMO CORPORATIONBlood pressure cuff hose for SURDIAL DX Hemodialysis System — NIPRO MEDICAL CORPORATIONB.BRAUN — B.Braun Avitum AGREXEED — ASAHIKASEI MEDICAL MT K.K.Xenium XPH Dialyzer — BAXTER INTERNATIONAL INC.VersiHD with GuideMe Software — NXSTAGE MEDICAL, INC.NIPRO ELISIO™ -H HEMODIALYZER — NIPRO MEDICAL CORPORATIONDiacap® — B.Braun Avitum AGREXEED — ASAHIKASEI MEDICAL MT K.K.EXPRESS FLUID WARMER — NXSTAGE MEDICAL, INC.Nipro Ultrafilter — NIPRO MEDICAL CORPORATIONNIPRO Cellentia™-H Hemodialyzer — NIPRO MEDICAL CORPORATIONRevaclear — Gambro Dialysatoren GmbH
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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