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510(k) K120505

FRESENIUS 2008T HEMODIALYSIS MACHINE by Fresenius Medical Care North America, Design Cente — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2012
Date Received
February 21, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Fresenius Medical Care North America, Design Cente

  • K123630 — FRESENIUS LIBERTY CYCLER (September 9, 2013)
  • K121421 — FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALE (January 17, 2013)
  • K120823 — BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTE (June 15, 2012)
  • K101715 — FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 (December 21, 2010)

Other clearances for product code KDI

  • K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124) (February 10, 2026)
  • K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U) (January 26, 2026)
  • K253518 — FX CorAL 40; FX CorAL 50 (December 18, 2025)
  • K243920 — Purema H Hemoconcentrator - Pediatric (September 19, 2025)
  • K250508 — AK 98 Dialysis Machine (955607) (August 1, 2025)
  • K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126) (June 13, 2025)
  • K243505 — 5008X Hemodialysis System (May 30, 2025)
  • K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (May 15, 2025)
  • K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemo (April 25, 2025)
  • K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (March 21, 2025)