Athelas Home is an AI-enabled medical device from Athelas, Inc., listed by FDA (510(k), K243348) with a decision date of 2026-02-06. Review panel: Hematology.
| FDA submission number | K243348 |
|---|---|
| Pathway | 510(k) |
| Company | Athelas, Inc. |
| Review panel (specialty) | Hematology |
| FDA decision date | 2026-02-06 |
| Decision | Substantially Equivalent |
| Product code | GKZ |
| Classification | Counter, Differential Cell |
| Device class | 2 |
| Regulation number | 864.5220 |
| Review time (calendar days) | 466 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Athelas, Inc. · All Hematology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.