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510(k) K242155

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) by NIKKISO CO., LTD. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2025
Date Received
July 23, 2024
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.

  • 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)
  • K953996 — NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS (March 19, 1997)
  • 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)
  • 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)
  • K243874 — FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX C (February 28, 2025)