# K233335: Tablo® Hemodialysis System

- Pathway: 510(k) (Traditional)
- Applicant: Outset Medical, Inc.
- Decided: Dec 5, 2023 after 67 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: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K921456 (1994). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223248: Tablo® Hemodialysis System, Outset Medical, Inc. (2023) Summary page 5.

## Most influential descendants
- K253412: Tablo Hemodialysis System (PN-0008000, PN-0006000U) (2026), 0 descendants of its own

## Recalls of this device
- Aug 1, 2024 · Class II · Z-0019-2025: Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BL
- Apr 30, 2024 · Class II · Z-2150-2024: A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat,
- Mar 6, 2024 · Class I · Z-1485-2024: Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl ac

## 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/K233335
Methodology: https://510kreport.com/methodology