Home / 510(k) Clearances / K210782

510(k) K210782

Tablo Cartridge by Outset Medical, Inc. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2021
Date Received
March 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
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)
  • 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 FJK

  • K251341 — VITAL Tubing Sets for Hemodialysis (January 16, 2026)
  • K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (October 2, 2025)
  • K243607 — Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (December 20, 2024)
  • K213992 — CombiSet Hemodialysis Blood Tubing Set (May 31, 2023)
  • K202796 — SANSIN Tubing Sets for Hemodialysis (September 6, 2021)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K171952 — Dimesol Tubing Sets for Hemodialysis (March 30, 2018)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)
  • K150304 — Oxyless Blood Tubing Set (February 24, 2016)
  • K140841 — TABLO CARTRIDGE (September 11, 2014)