Nikkiso Co., Ltd.
Shibuya-Ku, JP
NIKKISO CO., LTD. appears in FDA device records in Shibuya-Ku, JP. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Nikkiso Co., Ltd. between 1981 and 2025. The busiest year on record is 2025, with 3. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1997 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2016 | 1 |
| 2023 | 2 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242479 | 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 | KOC | Substantially Equivalent | |
| K242176 | 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) | KOC | Substantially Equivalent | |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | KDI | Substantially Equivalent | |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | KOC | Substantially Equivalent | |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | KOC | Substantially Equivalent | |
| K152938 | DBB-06 Hemodialysis Delivery System | KDI | Substantially Equivalent | |
| K091978 | DBB-06 HEMODIALYSIS DELIVERY SYSTEM | KDI | Substantially Equivalent | |
| K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P | KOC | Substantially Equivalent | |
| K061519 | MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM | KDI | Substantially Equivalent | |
| K953996 | NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS | KDI | Substantially Equivalent | |
| K803068 | NIKKISO ND-14 PARALLEL FLOW DIALYZER | FJG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014638255 | 3014638255 | NIKKISO CO., LTD. | 20-3 EBISU 4-CHOME,, SHIBUYA-KU Tokyo 150-6022 JP | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain