All apps · Sleep & breathing

Is Wesper FDA approved or cleared?

Yes. Wesper by Wesper, 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	Wesper
Maker	Wesper, Inc.
Care area	Sleep & breathing
What it does	At-home sleep monitoring / sleep apnea system with FDA-cleared sleep study capabilities
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	wesper.co
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.

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

Other apps in Sleep & breathing

AcuPebble™ Ox100 FDA verified
Aevice Wheeze Detection Module FDA verified
AeviceMD FDA verified
AireHealth Nebulizer FDA verified
ANNE Sleep FDA verified
Apple Watch Sleep Apnea Notifications FDA verified
Belun Ring FDA verified
CapMedic FDA verified

All certified sleep and breathing apps and devices

Search the full directory