Medical Device Manufacturer · US , Mchenry , IL

NIKKISO CO., LTD.

11 submissions · 11 cleared · Since 1981
11
Total
11
Cleared
0
Denied

NIKKISO CO., LTD. — FDA 510(k) Submissions

NIKKISO CO., LTD. has submitted 11 FDA 510(k) premarket notifications since 1981, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dialyzer, High Permeability With Or Without Sealed Dialysate System, Accessories, Blood Circuit, Hemodialysis, Dialyzer, Parallel Flow . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
K242155 · KDI Dialyzer, High... · Gastroenterology & Urology
May 2025 296d
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
K242176 · KOC Accessories, Blood... · Gastroenterology & Urology
May 2025 295d
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
K242479 · KOC Accessories, Blood... · Gastroenterology & Urology
May 2025 267d
Blood Tubing Lines for Hemodialysis AV06C-E
K231589 · KOC Accessories, Blood... · Gastroenterology & Urology
Jul 2023 57d
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
K230514 · KOC Accessories, Blood... · Gastroenterology & Urology
Jun 2023 112d
DBB-06 Hemodialysis Delivery System
K152938 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 2016 165d
DBB-06 HEMODIALYSIS DELIVERY SYSTEM
K091978 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 2010 267d
NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P
K082719 · KOC Accessories, Blood... · Gastroenterology & Urology
Mar 2009 194d
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
K061519 · KDI Dialyzer, High... · Gastroenterology & Urology
Sep 2007 484d
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS
K953996 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 1997 573d
NIKKISO ND-14 PARALLEL FLOW DIALYZER
K803068 · FJG Dialyzer, Parallel Flow · Gastroenterology & Urology
Mar 1981 90d
Filters