Data / Medical devices / Japan / Nikkiso Co., Ltd. - Shizuoka Plant
Nikkiso Co., Ltd. - Shizuoka Plant: FDA-registered device maker in Shizuoka-Ken, Japan, 3 510(k) clearances
Nikkiso Co., Ltd. - Shizuoka Plant is registered with the FDA (registration 8031561) in Shizuoka-Ken, Japan. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 15, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8031561
- FEI number
- 3002807721
- Address
- 498-1 Shizutani Makinohara-Shi, Shizuoka-Ken, Japan, 421-0496
- Owner or operator
- NIKKISO CO., LTD. (8031561)
- Roles
- Complaint file establishment, Contract manufacturer
- First device listed
- February 13, 2013
- Registered through
- 2027
- Brand names listed
- AL-CDC-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop), AV06C-E Blood Tubing Lines for Hemodialysis, C18SFD-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series, DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO), DIALYSATE FILTERS, LIPOSORBER LA-15 System, Liposorber LA-15 system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | 2 | Complaint file establishment | accessdata.fda.gov |
| Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients | PBN | f | Contract manufacturer | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Complaint file establishment | accessdata.fda.gov |
| Lipoprotein, Low Density, Removal | MMY | 3 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2025 | 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 | NIKKISO CO., LTD. | accessdata.fda.gov |
| May 15, 2025 | K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | KDI | Substantially Equivalent | NIKKISO CO., LTD. | accessdata.fda.gov |
| July 28, 2023 | K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | KOC | Substantially Equivalent | NIKKISO CO., LTD. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 24, 2021 | 88641 | Class II | Ongoing | DBB-06 Hemodialysis Delivery System | Device lacks premarket approval. | accessdata.fda.gov |
Compare with other makers
- All makers of Lipoprotein, Low Density, Removal
- All makers of Accessories, Blood Circuit, Hemodialysis
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients
Updated May 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.