Outset Medical, Inc.
Outset Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2016, most recent 2026, with 5 FDA device recalls on record.
Top product codes for Outset Medical, Inc.
FDA recalls by Outset Medical, Inc.
- Z-0019-2025 — Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
- Z-2150-2024 — TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.
- Z-1485-2024 — Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
- Z-1351-2023 — Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.
- Z-0813-2022 — Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Outset Medical, Inc.
- K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U)
- K232776 — Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer
- K233335 — Tablo® Hemodialysis System
- K223248 — Tablo® Hemodialysis System
- K211370 — Tablo Hemodialysis System
- K210782 — Tablo Cartridge
- K200741 — Tablo Hemodialysis System
- K190793 — Tablo Hemodialysis System, Tablo Cartridge
- K160881 — Tablo Console
Data sourced from openFDA. This site is unofficial and independent of the FDA.