Outset Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Outset Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Tablo Hemodialysis System (PN-0008000, PN-0006000U), Tablo® Hemodialysis System, Tablo® Hemodialysis System
9
Total
9
Cleared
0
Denied
Outset Medical, Inc. has 9 FDA 510(k) cleared medical devices. Based in San Jose, US.
Latest FDA clearance: Jan 2026. Active since 2016. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Outset Medical, Inc. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Outset Medical, Inc.
9 devices
Cleared
Jan 26, 2026
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
Gastroenterology & Urology
118d
Cleared
May 03, 2024
Tablo® Hemodialysis System
Gastroenterology & Urology
235d
Cleared
Dec 05, 2023
Tablo® Hemodialysis System
Gastroenterology & Urology
67d
Cleared
Jun 21, 2023
Tablo® Hemodialysis System
Gastroenterology & Urology
243d
Cleared
Jul 29, 2022
Tablo Hemodialysis System
Gastroenterology & Urology
451d
Cleared
Nov 26, 2021
Tablo Cartridge
Gastroenterology & Urology
255d
Cleared
CT
Mar 31, 2020
Tablo Hemodialysis System
Gastroenterology & Urology
8d
Cleared
Dec 12, 2019
Tablo Hemodialysis System, Tablo Cartridge
Gastroenterology & Urology
259d
Cleared
Nov 15, 2016
Tablo Console
Gastroenterology & Urology
230d