Data / Medical devices / Japan / Nipro Medical Industries Ltd.
Nipro Medical Industries Ltd.: FDA-registered device maker in TATEBAYASHI-SHI Gunma, Japan, 5 510(k) clearances
Nipro Medical Industries Ltd. is registered with the FDA (registration 9611446) in TATEBAYASHI-SHI Gunma, Japan. It lists 10 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611446
- FEI number
- 3002807725
- Address
- 2-19-64, Matsubara, TATEBAYASHI-SHI Gunma, Japan, 374-8518
- Owner or operator
- NIPRO CORPORATION (8030375)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 16, 2004
- Registered through
- 2026
- Brand names listed
- AQUALiner, BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Hold, Dental Needle, Needle, Nipro Blood Collection Needle, Ophthalmic Needle, PRESSONE, Safe Touch PSV Winged Infusion Set (with or without filter) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Contract manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Needle, Ophthalmic Suturing | HNM | 1 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Contract manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Contract manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | 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 |
|---|---|---|---|---|---|---|
| March 24, 2026 | K253047 | PRESSONE | FMI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| December 5, 2013 | K132153 | SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER | FOZ | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| July 7, 2000 | K001251 | SNIPER, MODEL OR-3872XX SERIES | DQX | Substantially Equivalent | Nipro Medical Corp. | accessdata.fda.gov |
| February 14, 2000 | K992699 | NIPRO BLOOD COLLECTION NEEDLE | FMI | Substantially Equivalent | Nipro Medical Corp. | accessdata.fda.gov |
| January 13, 2000 | K992729 | NIPRO LUER ADAPTOR | FMI | Substantially Equivalent | Nipro Medical Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Container, Specimen, Sterile
- All makers of Wire, Guide, Catheter
- All makers of Needle, Dental
- All makers of Set, Administration, Intravascular
Updated March 24, 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.