All apps · Heart & circulation

Is Qardio Arm FDA approved or cleared?

Yes. Qardio Arm by Qardio, Inc. is named in the FDA register with a 510(k) clearance, first authorised in 2014, latest decision in 2022.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

This product appears to be discontinued or no longer supported by its maker.

At a glance

Product	Qardio Arm
Maker	Qardio, Inc.
Care area	Heart & circulation
What it does	Wireless blood pressure monitor with smartphone connectivity
FDA	510(k), latest decision 2022
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	qardio.com
Status	FDA verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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