Cala Health, Inc. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Cala kIQ Plus510(k)Mar 17, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 17, 2026
Cala kIQ510(k)Jan 16, 2025Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jan 16, 2025
Cala kIQ510(k)Nov 22, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 22, 2024
Cala kIQ510(k)Nov 22, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 22, 2022
Cala Trio510(k)Oct 5, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 5, 2021