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Outset Medical, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories2
Latest FDA decision2026-01-26

SEC Filings: 1 filings on record. Latest: 10-Q (2026-08-06). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K253412 Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI2026-01-26 View
510(k) K232776 Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerKDI2024-05-03 View
510(k) K233335 Tablo® Hemodialysis SystemKDI2023-12-05 View
510(k) K223248 Tablo® Hemodialysis SystemKDI2023-06-21 View
510(k) K211370 Tablo Hemodialysis SystemKDI2022-07-29 View
510(k) K210782 Tablo CartridgeFJK2021-11-26 View
510(k) K200741 Tablo Hemodialysis SystemKDI2020-03-31 View
510(k) K190793 Tablo Hemodialysis System, Tablo CartridgeKDI2019-12-12 View
510(k) K160881 Tablo ConsoleKDI2016-11-15 View
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