Sleepnet Corporation FDA Approvals

0 new drug approvals and 8 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
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask510(k)Jan 15, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jan 15, 2026
Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask510(k)Oct 18, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Oct 18, 2024
Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask510(k)Aug 28, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Aug 28, 2024
Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask510(k)Jul 10, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Special)	Jul 10, 2024
Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask510(k)Jun 27, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Special)	Jun 27, 2024
iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask510(k)Jun 15, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Special)	Jun 15, 2024
iQ 2 Nasal Mask, Phantom 2 Nasal Mask510(k)Jan 10, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jan 10, 2022
Innova Nasal Non-Vented Mask510(k)Apr 30, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 30, 2021