Data / Medical devices / South Korea / Korot Co., Ltd
Korot Co., Ltd: FDA-registered device maker in Cheonan-si Chungnam, South Korea, 2 510(k) clearances
Korot Co., Ltd is registered with the FDA (registration 3027645104) in Cheonan-si Chungnam, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 14, 2025. Registered through 2026. FDA data exported November 2, 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
- 3027645104
- Address
- 1-102, 330, Yeongok-gil Ipjang-myeon, Seobuk-gu, Cheonan-si Chungnam, South Korea, 31026
- Owner or operator
- KOROT Co., Ltd (10088436)
- Roles
- Manufacturer
- First device listed
- July 21, 2023
- Registered through
- 2026
- Brand names listed
- BPBIO280KV, KOROT P3 Accurate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 14, 2025 | K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | DXN | Substantially Equivalent | Korot Co., Ltd. | accessdata.fda.gov |
| October 7, 2022 | K221764 | InBody Blood pressure monitor, Model BPBIO480KV | DXN | Substantially Equivalent | Inbody Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 14, 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.