Outset Medical, Inc. FDA Approvals

0 new drug approvals and 6 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
Tablo Hemodialysis System (PN-0008000, PN-0006000U)510(k)Jan 26, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 26, 2026
Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer510(k)May 3, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 3, 2024
Tablo® Hemodialysis System510(k)Dec 5, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 5, 2023
Tablo® Hemodialysis System510(k)Jun 21, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 21, 2023
Tablo Hemodialysis System510(k)Jul 29, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 29, 2022
Tablo Cartridge510(k)Nov 26, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 26, 2021