Data / Medical devices / Japan / Konan Medical, Inc.
Konan Medical, Inc.: FDA-registered device maker in NISHINOMIYA Hyogo, Japan, 3 510(k) clearances
Konan Medical, Inc. is registered with the FDA (registration 9680854) in NISHINOMIYA Hyogo, Japan. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 15, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9680854
- FEI number
- 1000494121
- Address
- 10-29 Miyanishi-Cho, NISHINOMIYA Hyogo, Japan, 662-0976
- Owner or operator
- KONAN MEDICAL, INC. (9011976)
- Roles
- Manufacturer
- First device listed
- November 27, 2007
- Registered through
- 2027
- Brand names listed
- CellChek 20 rc, CellChek D, Kerato Analyzer, Konan Specular Microscope XVII, Konan Specular Microscope XX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Microscope, Specular | NQE | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Management, Ophthalmic | NFJ | 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 |
|---|---|---|---|---|---|---|
| June 15, 2021 | K203244 | CellChek 20 rc | NFJ | Substantially Equivalent | Konan Medical, Inc. | accessdata.fda.gov |
| March 26, 2020 | K191558 | Konan Specular Microscope XVII | NQE | Substantially Equivalent | Konan Medical, Inc. | accessdata.fda.gov |
| March 19, 2004 | K040373 | KERATO ANALYZER (EKA) | NQE | Substantially Equivalent | Konan Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 15, 2021. 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.