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Outset Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
5 (1 Class I)
510(k) Clearances
10
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0019-2025Class IITablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo HemodiaAugust 1, 2024
Z-2150-2024Class IITabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (April 30, 2024
Z-1485-2024Class ITablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001March 6, 2024
Z-1351-2023Class IIOutset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-conJanuary 24, 2023
Z-0813-2022Class IIOutset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000January 20, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)January 26, 2026
K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerMay 3, 2024
K233335Tablo® Hemodialysis SystemDecember 5, 2023
K223248Tablo® Hemodialysis SystemJune 21, 2023
K211370Tablo Hemodialysis SystemJuly 29, 2022
K210782Tablo CartridgeNovember 26, 2021
K200741Tablo Hemodialysis SystemMarch 31, 2020
K190793Tablo Hemodialysis System, Tablo CartridgeDecember 12, 2019
K160881Tablo ConsoleNovember 15, 2016
K150880Tablo Console with Wireless CapabilityMay 1, 2015