# K190793: Tablo Hemodialysis System, Tablo Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Outset Medical, Inc.
- Decided: Dec 12, 2019 after 259 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921456 (1994). 16 ancestors in all.
2 later devices descend 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)
- K160881: Tablo Console, Outset Medical, Inc. (2016) Summary page 4.
- K140841: Tablo Cartridge, Home Dialysis Plus (2014) Summary page 4.

## Most influential descendants
- K210782: Tablo Cartridge (2021), 1 descendant of its own
- K233798: Moda-flx Hemodialysis System and Cartridge (2024), 0 descendants of its own

## Recalls of this device
- Jan 24, 2023 · Class II · Z-1351-2023: An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
- Jan 20, 2022 · Class II · Z-0813-2022: Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

## Indications for use
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. Treatments must be administered under physician’s prescription, with a trained individual available as needed who is considered competent in the use of the device by the prescribing physician. 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/K190793
Methodology: https://510kreport.com/methodology