Is XK300-H & Xkare App FDA approved or cleared?
Yes. XK300-H & Xkare App by Xandar Kardian, Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2021.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | XK300-H & Xkare App |
|---|---|
| Maker | Xandar Kardian, Inc. |
| Care area | Vital signs & remote monitoring |
| What it does | Advanced health monitoring system with multi-parameter sensing |
| FDA | 510(k), latest decision 2021 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | xkcorp.com |
| Status | FDA verified |
| Last checked | 6 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes