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510(k) K253412

Tablo Hemodialysis System (PN-0008000, PN-0006000U) by Outset Medical, Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2026
Date Received
September 30, 2025
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.

  • 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)
  • K200741 — Tablo Hemodialysis System (March 31, 2020)
  • 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)
  • 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)
  • K243874 — FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX C (February 28, 2025)