# K223248: Tablo® Hemodialysis System

- Pathway: 510(k) (Traditional)
- Applicant: Outset Medical, Inc.
- Decided: Jun 21, 2023 after 243 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: 12 generations back to K921456 (1994). 14 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211370: Tablo Hemodialysis System, Outset Medical, Inc. (2022) Summary page 4.

## Most influential descendants
- 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
- K232776: Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer (2024), 0 descendants of its own

## 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. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

Source page: https://510kreport.com/device/K223248
Methodology: https://510kreport.com/methodology