Data / Medical devices / Japan / Kaneka Corporation Osaka Plant
Kaneka Corporation Osaka Plant: FDA-registered device maker in Settsu-shi Osaka, Japan, 12 510(k) clearances and 2 PMA approvals
Kaneka Corporation Osaka Plant is registered with the FDA (registration 9614654) in Settsu-shi Osaka, Japan. It lists 10 device types. The FDA files 12 510(k) clearances and 2 PMA approvals under its listings, the newest dated March 26, 2021. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9614654
- FEI number
- 3002808904
- Address
- 5-1-1, Torikai-nishi, Settsu-shi Osaka, Japan, 5660072
- Owner or operator
- KANEKA CORP. (9005249)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 16, 2007
- Registered through
- 2026
- Brand names listed
- Crosperio OTW, Crosperio RX, Crosstella OTW, Crosstella RX, EDG v4, Lacriflow CL, Liposorber LA-15 System, Liposorber LA-15 system and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients | PBN | f | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Beta 2-Microglobulin Apheresis Column | PDI | f | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Manufacturer | accessdata.fda.gov |
| Device, Neurovascular Embolization | HCG | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Lacrimal Stents And Intubation Sets | OKS | U | Exporter to the US, Specification developer | accessdata.fda.gov |
| Lipoprotein, Low Density, Removal | MMY | 3 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma | MDP | 3 | Exporter to the US | 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 26, 2021 | K210638 | i-ED COIL System | HCG | Substantially Equivalent | Kaneka Medical America, LLC | accessdata.fda.gov |
| March 19, 2018 | K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| July 7, 2017 | K170941 | RX NC Takeru PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| April 18, 2017 | K170247 | Lacriflow CL | OKS | Substantially Equivalent | Kaneka Pharma America, LLC | accessdata.fda.gov |
| April 7, 2017 | K163372 | RX Takeru Balloon Dilatation Catheter | LOX | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| January 11, 2017 | K163479 | R2P Metacross RX | LIT | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| April 29, 2016 | K160013 | Crosperio OTW | LIT | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| April 29, 2016 | K160004 | Crosstella OTW | LIT | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| January 22, 2016 | K152887 | Crosperio RX PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| January 22, 2016 | K152873 | Crosstella RX Balloon Dilatation Catheter | LIT | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| September 24, 2015 | K152080 | Metacross OTW PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| August 3, 2015 | K150865 | Metacross RX PTA Balloon Dilitation Catheter | DQY | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 21, 1996 | P910018 | LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). | MMY | 37 | June 16, 2026 | accessdata.fda.gov |
| July 5, 1983 | P820033 | PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR | MDP | 16 | April 9, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Lipoprotein, Low Density, Removal
- All makers of Device, Vascular, For Promoting Embolization
- All makers of Device, Neurovascular Embolization
Updated June 16, 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.