MY01, Inc. FDA Approvals

0 new drug approvals and 4 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
MY01 Continuous Compartmental Pressure Monitor510(k)Jan 16, 2026	—	510(k)Substantially Equivalent (Traditional)	Jan 16, 2026
MY01 Continuous Compartmental Pressure Monitor510(k)Mar 13, 2025	—	510(k)Substantially Equivalent (Traditional)	Mar 13, 2025
MY01 Continuous Compartmental Pressure Monitor510(k)May 24, 2022	—	510(k)Substantially Equivalent (Traditional)	May 24, 2022
MY01 Continuous Compartmental Pressure Monitor510(k)Apr 22, 2021	—	510(k)Substantially Equivalent (Traditional)	Apr 22, 2021