Respironics, 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
Altis Full Face Mask510(k)Sep 25, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Sep 25, 2026
AF531 Oro-Nasal SE Face Mask510(k)Dec 30, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 30, 2024
Therapy Mask 3100 NC/SP510(k)Jul 28, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Special)	Jul 28, 2023
DreamWear Silicone Pillows Mask510(k)Aug 24, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Aug 24, 2021
Magneto Nasal Mask510(k)Jul 12, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 12, 2021