Outset Medical Nabs FDA Clearance for TabloCart

Outset Medical today announced the FDA 510(k) clearance of its TabloCart with prefiltration, an optional accessory for the Tablo Hemodialysis system. Tablo, which can be used for outpatient, hospital, and home care, simplifies dialysis operation by only requiring access to tap water and a standard electrical outlet to work.

TabloCart is designed to enhance the user experience of healthcare providers using Tablo by delivering flexibility in two versions. One version of the cart comes with additional storage features while the other features water prefiltration capabilities. The prefiltration has three customizable options to adapt to varying water conditions and has a booster pump to increase incoming water pressure. The cart comes with 360-degree rotating wheels and directional locking rear wheels.

Outset said it has resumed the distribution of the cart with prefiltration and has product ready to ship to US customers.

"With the FDA's clearance of TabloCart with prefiltration, we have delivered features to the Tablo Hemodialysis System that increase the flexibility for nurses and health systems to serve patients from the ICU to the bedside,” said Leslie Trigg, chair and CEO of Outset. “Today’s announcement underscores Outset Medical's commitment to innovation and our ongoing dedication to transforming the landscape of dialysis treatment.”