Home / 510(k) Clearances / K153344

510(k) K153344

Asahi REXEED-S Series Dialyzer by Asahi Kasei Medical Co., Ltd. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2015
Date Received
November 19, 2015
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 Asahi Kasei Medical Co., Ltd.

  • K162248 — Asahi ViE-U Series Dialyzer (May 3, 2017)
  • K121409 — ASAHI REXEED-SX/LX SERIES DIALYZER (February 6, 2013)
  • K082515 — ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, (October 3, 2008)
  • K051187 — REXEED SERIES DIALYZERS (June 8, 2005)

Other clearances for product code KDI

  • K252377 — NxStage System One with NxView (May 15, 2026)
  • K260533 — ELISIO™-H (March 19, 2026)
  • 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)