Data / Medical devices / United States / Athelas
Athelas: FDA-registered device maker in Mountain View, CA, United States, 4 510(k) clearances
Athelas is registered with the FDA (registration 3013445220) in Mountain View, CA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 6, 2026. 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
- 3013445220
- Address
- 1300 Terra Bella Ave STE 200, Mountain View, CA, United States, 94043
- Owner or operator
- Athelas (10053154)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 12, 2019
- Registered through
- 2026
- Brand names listed
- Athelas Home, Athelas One, AthelasBP01, Commure Home, Commure One
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Counter, Differential Cell | GKZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 6, 2026 | K243348 | Athelas Home | GKZ | Substantially Equivalent | Athelas, Inc. | accessdata.fda.gov |
| March 22, 2022 | K200828 | Athelas Home | GKZ | Substantially Equivalent | Athelas, Inc. | accessdata.fda.gov |
| March 9, 2021 | K202891 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| November 5, 2018 | K181288 | Athelas One | GKZ | Substantially Equivalent | Athelas, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Counter, Differential Cell
Updated February 6, 2026. 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.