Data / Medical devices / South Korea / Xandar Kardian Korea Inc.
Xandar Kardian Korea Inc.: FDA-registered device maker in Seoul, South Korea, 1 510(k) clearance
Xandar Kardian Korea Inc. is registered with the FDA (registration 3026751377) in Seoul, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 26, 2021. 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
- 3026751377
- Address
- 2F, 27, Gyeonghuigung-gil, Jongno-gu, Seoul, South Korea, 03176
- Owner or operator
- Xandar Kardian Inc. (10087145)
- Roles
- Manufacturer
- First device listed
- January 17, 2023
- Registered through
- 2026
- Brand names listed
- XK300, XK300-E
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 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 |
|---|---|---|---|---|---|---|
| April 26, 2021 | K202464 | Vital Sign Monitoring Sensor (Model :XK300) | DRT | Substantially Equivalent | Xandar Kardian, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- All makers of Monitor, Breathing Frequency
Updated April 26, 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.