KDI
NXSTAGE SYSTEM ONE
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 343
Adverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KDI
1–100 of 343- K260533 — ELISIO-H
- K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124)
- K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U)
- K253518 — FX CorAL 40; FX CorAL 50
- K243920 — Purema H Hemoconcentrator - Pediatric
- K250508 — AK 98 Dialysis Machine (955607)
- K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
- K243505 — 5008X Hemodialysis System
- K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
- K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
- K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
- K243874 — FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)
- K233798 — Moda-flx Hemodialysis System and Cartridge
- K233557 — HemoCare Hemodialysis System
- K240394 — multiFlux 1000 (F00012408)
- K232776 — Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer
- K232803 — NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
- K232171 — Purema® H Hemoconcentrator (EtO Sterilized)
- K231534 — 5008X Hemodialysis System
- K231125 — 2008T BlueStar Hemodialysis Machine
- K233335 — Tablo® Hemodialysis System
- K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
- K230632 — VersiHD with GuideMe software
- K223248 — Tablo® Hemodialysis System
- K231406 — ClearumTM HS
- K220721 — FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
- K220281 — multiFiltratePRO System
- K222067 — SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
- K222952 — 2008T BlueStar Hemodailysis Machine
- K211370 — Tablo Hemodialysis System
- K210575 — HDF Assist Mudule, HDF Infusion Set and Substitution Filter
- K212216 — Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
- K213639 — Revaclear 500, Revaclear 400, Revaclear 300
- K210661 — SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
- K201809 — AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
- K203062 — Optiflux Series of Dialyzers F160NR, F180NR, F200NR
- K193670 — SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
- K193542 — Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
- K192707 — Optiflux F180NR Dialyzer
- K193005 — DIMI RRT System
- K192928 — Optiflux Enexa F500 Dialyzer
- K200741 — Tablo Hemodialysis System
- K193482 — PrisMax System Version 3
- K192756 — Aquadex FlexFlow System 2.0
- K190793 — Tablo Hemodialysis System, Tablo Cartridge
- K183158 — NxStage Cartridge Express with Speedswap
- K190910 — PrisMax System Version 2
- K182940 — Surdial DX Hemodialysis System
- K173972 — 2008T BlueStar Hemodialysis Machine
- K171671 — Prismaflex System 8.10
- K170790 — SAM CRRT Unit, SAM Cassette CRRT
- K171331 — NxStage System One
- K170574 — Diacap Pro Dialyzer
- K170469 — NxStage System One Plus
- K162248 — Asahi ViE-U Series Dialyzer
- K163530 — PrisMax Control Unit
- K162488 — Optiflux dialyzer
- K160444 — FB-U Hemodialyzer
- K160558 — RAPIDO HOLLOW-FIBRE DIALYZERS
- K160881 — Tablo Console
- K153449 — 2008K2 Hemodialysis Machine
- K152938 — DBB-06 Hemodialysis Delivery System
- K143482 — xevonta dialyzer
- K153344 — Asahi REXEED-S Series Dialyzer
- K150708 — 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
- K152367 — Optiflux dialyzer
- K150880 — Tablo Console with Wireless Capability
- K143313 — NxStage Therapeutic Plasma Exchange (TPE) Cartridge
- K140866 — TABLO CONSOLE
- K133299 — ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
- K140526 — NXSTAGE SYSTEM ONE
- K140191 — ELISIO-H HEMODIALYZER
- K133547 — NXSTAGE SYSTEM ONE WITH NXVIEW
- K132602 — STREAMLINE EXPRESS
- K123262 — OPTIFLUX ULTRA DIALYZER
- K131516 — PRISMAFLEX SYSTEM 7.10
- K131050 — NXSTAGE 1.6M2 DIALYZER
- K131935 — ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
- K131381 — ELISIO-H HEMODIALYZER
- K131908 — 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
- K123288 — HEMOCONCENTRATOR
- K122343 — PUREFLUX-H HEMODIALYZER
- K130039 — REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
- K122347 — ELISIO-H AND ELISIO-M HEMODIALYZERS
- K122051 — NXSTAGE SYSTEM ONE
- K123395 — NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
- K121409 — ASAHI REXEED-SX/LX SERIES DIALYZER
- K113023 — STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
- K121341 — FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
- K121497 — VENOFER PUMP
- K112314 — NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
- K120505 — FRESENIUS 2008T HEMODIALYSIS MACHINE
- K120017 — FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
- K113427 — FRESENIUS 2008T HEMODIALYSIS MACHINE
- K111639 — FRESENIUS 2008T HEMODIALYSIS MACHINE
- K110823 — PRISMAFLEX
- K103832 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM
- K103564 — VENOFER PUMP
- K101715 — FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
- K093069 — NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.