Tyto Care , Ltd. FDA Approvals

0 new drug approvals and 7 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
Tyto Insights for Wheeze Detection (with PCCP)510(k)Jun 2, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jun 2, 2026
Tyto Insights for Eardrum Bulging Detection510(k)Mar 17, 2026Ear, Nose, Throat	Ear, Nose, Throat	510(k)Unknown (Direct)	Mar 17, 2026
Tyto Stethoscope (G3)510(k)Mar 12, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 12, 2026
Tyto Insights for Rhonchi Detection510(k)Apr 7, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 7, 2025
Tyto Insights for Crackles Detection510(k)Jul 2, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 2, 2024
Tyto Insights for Wheeze Detection510(k)Dec 13, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 13, 2023
TytoCare Lung Sounds Analyzer510(k)Feb 24, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Feb 24, 2023