# K211370: Tablo Hemodialysis System

- Pathway: 510(k) (Traditional)
- Applicant: Outset Medical, Inc.
- Decided: Jul 29, 2022 after 451 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K921456 (1994). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200741: Tablo Hemodialysis System, Outset Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K223248: Tablo® Hemodialysis System (2023), 4 descendants of its own
- K233335: Tablo® Hemodialysis System (2023), 1 descendant of its own
- K253412: Tablo Hemodialysis System (PN-0008000, PN-0006000U) (2026), 0 descendants of its own
- K233798: Moda-flx Hemodialysis System and Cartridge (2024), 0 descendants of its own
- K233557: HemoCare Hemodialysis System (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.

## 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 and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home.

Source page: https://510kreport.com/device/K211370
Methodology: https://510kreport.com/methodology