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Tablo Console with Wireless Capability

FDA 510(k)

Class II (US FDA 510(k))

510(k) K150880

by Outset Medical

Identifiers

510(k) Number
K150880 FDA 510(k)
FDA Product Code
KDI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5860 FDA 510(k)
Regulation Number
876.5860 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tablo Console with Wireless Capability is a hemodialysis system designed for critical care environments. It supports high-permeability dialysis procedures, facilitating automated treatment management and integration with clinical workflows.

This reusable device features wireless connectivity for remote monitoring and cloud-based reporting, ensuring seamless data transfer. It includes internal and external transducer protectors to maintain accurate pressure monitoring during hemodialysis. Authorized under FDA 510(k) clearance (K150880), it adheres to regulatory standards for hemodialysis systems.

Tablo Console with Wireless Capability

Frequently asked questions

What types of dialysis procedures is the Tablo Console with Wireless Capability designed to support in critical care settings?

The Tablo Console is specifically designed to support high-permeability dialysis procedures, which are often used in critical care environments to efficiently remove waste and excess fluids from patients. Its automated treatment management and integration with clinical workflows make it suitable for complex cases requiring precise monitoring and control.

How is the wireless capability of the Tablo Console beneficial for clinicians and patients?

The wireless connectivity of the Tablo Console enables remote monitoring and cloud-based reporting, allowing clinicians to track patient data in real time from anywhere within the facility. This enhances workflow efficiency, reduces manual documentation, and ensures seamless data transfer for better-informed clinical decisions.

Is the Tablo Console reusable, and if so, how does this impact maintenance and cleaning protocols?

Yes, the Tablo Console is a reusable device, which means it must be thoroughly cleaned and maintained between uses to ensure patient safety and device functionality. The design includes internal and external transducer protectors to help maintain accurate pressure monitoring during hemodialysis, but proper cleaning and sterilization protocols must still be followed as per manufacturer guidelines.

What regulatory pathway was followed for the FDA clearance of the Tablo Console with Wireless Capability?

The Tablo Console received FDA clearance through a 510(k) premarket notification process, specifically under the classification of Special 510(k). It was determined to be substantially equivalent to a legally marketed predicate device, adhering to regulatory standards for hemodialysis systems. The clearance number is K150880, and it falls under the product code KDI for dialysis machines.

Does the Tablo Console support integration with other clinical systems or workflows, and how might this benefit dialysis units?

While the device itself is designed for automated treatment management and wireless connectivity, the data provided does not explicitly detail integration capabilities with third-party clinical systems. However, its wireless and cloud-based reporting features suggest it is built to streamline workflows by enabling seamless data transfer, which could reduce manual entry errors and improve coordination between dialysis units and other healthcare systems.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tablo - Outset Medical, Tablo ICU - Outset Medical, PDF PN-0004205 Rev 05 Outset Medical Tablo User Manual, Tablo by Outset Medical | SDV Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Outset Medical

Sources (1)

  • FDA 510(k) K150880 24 fields · synced Sep 20, 2026