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510(k) K200741

Tablo Hemodialysis System by Outset Medical, Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2020
Date Received
March 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Outset Medical, Inc.

  • K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U) (January 26, 2026)
  • K232776 — Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer (May 3, 2024)
  • K233335 — Tablo® Hemodialysis System (December 5, 2023)
  • K223248 — Tablo® Hemodialysis System (June 21, 2023)
  • K211370 — Tablo Hemodialysis System (July 29, 2022)
  • K210782 — Tablo Cartridge (November 26, 2021)
  • K190793 — Tablo Hemodialysis System, Tablo Cartridge (December 12, 2019)
  • K160881 — Tablo Console (November 15, 2016)
  • K150880 — Tablo Console with Wireless Capability (May 1, 2015)

Other clearances for product code KDI

  • K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124) (February 10, 2026)
  • K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U) (January 26, 2026)
  • K253518 — FX CorAL 40; FX CorAL 50 (December 18, 2025)
  • K243920 — Purema H Hemoconcentrator - Pediatric (September 19, 2025)
  • K250508 — AK 98 Dialysis Machine (955607) (August 1, 2025)
  • K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126) (June 13, 2025)
  • K243505 — 5008X Hemodialysis System (May 30, 2025)
  • K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (May 15, 2025)
  • K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemo (April 25, 2025)
  • K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (March 21, 2025)