Data / Medical devices / Japan / Nipro Corporation Odate Factory
Nipro Corporation Odate Factory: FDA-registered device maker in ODATE-SHI Akita, Japan, 7 510(k) clearances
Nipro Corporation Odate Factory is registered with the FDA (registration 9610987) in ODATE-SHI Akita, Japan. It lists 10 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 28, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9610987
- FEI number
- 3002807710
- Address
- 8-7, Hanukiyachi, Niida, ODATE-SHI Akita, Japan, 018-5794
- Owner or operator
- NIPRO CORPORATION (8030375)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 18, 2001
- Registered through
- 2026
- Brand names listed
- ELISIO-09H and 25H., ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M., ELISIO-HX, ELISIO-H, NIPRO Cellentia Dialyzer, NIPRO SAFELET CATH, Surdial DX Hemodialysis System and Accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Secondary | JIT | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Manufacturer | accessdata.fda.gov |
| Fibrin Split Products | GHH | 2 | Contract manufacturer | accessdata.fda.gov |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | 2 | Contract manufacturer | accessdata.fda.gov |
| Hemodialyzer With Expanded Solute Removal Profile | QAX | 2 | Manufacturer | accessdata.fda.gov |
| Immunoassay Method, Troponin Subunit | MMI | 2 | Contract manufacturer | accessdata.fda.gov |
| Myoglobin, Antigen, Antiserum, Control | DDR | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Test, C-Reactive Protein | DCN | 2 | Contract manufacturer | accessdata.fda.gov |
| Test, Natriuretic Peptide | NBC | 2 | 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 |
|---|---|---|---|---|---|---|
| July 28, 2026 | K261399 | ELISIO-HX | QAX | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| March 19, 2026 | K260533 | ELISIO-H | KDI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| July 19, 2019 | K182940 | Surdial DX Hemodialysis System | KDI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| February 8, 2017 | K160444 | FB-U Hemodialyzer | KDI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| April 14, 2014 | K140191 | ELISIO-H HEMODIALYZER | KDI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| December 20, 2013 | K131935 | ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER | KDI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| March 28, 1996 | K960051 | NIPRO SAFELET CATH | FOZ | Substantially Equivalent | Nissho Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Immunoassay Method, Troponin Subunit
- All makers of Calibrator, Secondary
- All makers of Test, Natriuretic Peptide
- All makers of Fluorometric Method, Cpk Or Isoenzymes
- All makers of Myoglobin, Antigen, Antiserum, Control
Updated July 28, 2026. 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.