# K253412: Tablo Hemodialysis System (PN-0008000, PN-0006000U)

- Pathway: 510(k) (Traditional)
- Applicant: Outset Medical, Inc.
- Decided: Jan 26, 2026 after 118 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: 14 generations back to K921456 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233335: Tablo® Hemodialysis System, Outset Medical, Inc. (2023) Summary page 5.

## Indications for use
The Tablo® Hemodialysis System and TabloCart™ are indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility, and/or in the home. Treatments must be administered under a physician’s prescription and observed by a trained individual who is considered competent in the use of the device. 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/K253412
Methodology: https://510kreport.com/methodology