# K160881: Tablo Console

- Pathway: 510(k) (Traditional)
- Applicant: Outset Medical, Inc.
- Decided: Nov 15, 2016 after 230 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921456 (1994). 11 ancestors in all.
10 later devices descend from it; 2 cite it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150880: Tablo Console with Wireless Capability, Outset Medical (2015) Summary page 4.

## Most influential descendants
- K200741: Tablo Hemodialysis System (2020), 7 descendants of its own
- K211370: Tablo Hemodialysis System (2022), 6 descendants of its own
- K223248: Tablo® Hemodialysis System (2023), 4 descendants of its own
- K190793: Tablo Hemodialysis System, Tablo Cartridge (2019), 2 descendants of its own
- K233335: Tablo® Hemodialysis System (2023), 1 descendant of its own

## Indications for use
The Tablo™ 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.

Source page: https://510kreport.com/device/K160881
Methodology: https://510kreport.com/methodology