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510(k) K953996

NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS by NIKKISO CO., LTD. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1997
Date Received
August 24, 1995
Clearance Type
Traditional
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 NIKKISO CO., LTD.

  • K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (May 15, 2025)
  • K242176 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR (May 15, 2025)
  • K242479 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR (May 15, 2025)
  • K231589 — Blood Tubing Lines for Hemodialysis AV06C-E (July 28, 2023)
  • K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for (June 16, 2023)
  • K152938 — DBB-06 Hemodialysis Delivery System (March 18, 2016)
  • K091978 — DBB-06 HEMODIALYSIS DELIVERY SYSTEM (March 25, 2010)
  • K082719 — NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, (March 30, 2009)
  • K061519 — MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM (September 28, 2007)
  • K803068 — NIKKISO ND-14 PARALLEL FLOW DIALYZER (March 4, 1981)

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)