# K210782: Tablo Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Outset Medical, Inc.
- Decided: Nov 26, 2021 after 255 days
- Product code: FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K921456 (1994). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190793: Tablo Hemodialysis System, Tablo Cartridge, Outset Medical, Inc. (2019) Summary page 4.

## Most influential descendants
- K233798: Moda-flx Hemodialysis System and Cartridge (2024), 0 descendants of its own

## Indications for use
The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.

Source page: https://510kreport.com/device/K210782
Methodology: https://510kreport.com/methodology