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Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO

FDA 510(k)

Class II (US FDA 510(k))

510(k) K980906

by Transonic Systems Inc.

Identifiers

510(k) Number
K980906 FDA 510(k)
FDA Product Code
MQS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5820 FDA 510(k)
Regulation Number
876.5820 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO is a System, Hemodialysis, Access Recirculation Monitoring device designed to estimate cardiac output during hemodialysis. It employs ultrasound dilution technology to assess hemodynamic status in patients receiving dialysis treatment, providing real-time monitoring of blood flow dynamics and vascular access performance. This device aids clinicians in evaluating recirculation and ensuring optimal dialysis efficacy in non-critical care settings.

This device is intended for single-use in hemodialysis facilities and requires trained medical personnel for operation. Supplied sterile, it is regulated under FDA 510(k) clearance (K980906) and classified as a Class II medical device (FDA code 876.5820). The monitor is compatible with standard hemodialysis equipment and is intended for use in non-MRI environments. Storage instructions and additional regulatory details are specified in the manufacturer’s instructions for use.

Frequently asked questions

What is the primary purpose of the Transonic Hemodialysis Monitor, Cardiac Output (Model HD01-CO)?

The Transonic Hemodialysis Monitor, Cardiac Output (Model HD01-CO) is designed to estimate cardiac output during hemodialysis using ultrasound dilution technology. It helps clinicians monitor blood flow dynamics and assess vascular access performance, particularly to evaluate recirculation and ensure effective dialysis in non-critical care settings.

Is this device intended for reuse or single-use, and how does that affect its use in a hemodialysis facility?

The Transonic Hemodialysis Monitor, Cardiac Output (Model HD01-CO) is explicitly designed for single-use in hemodialysis facilities. This means each device is intended for one patient session, reducing the risk of cross-contamination and ensuring sterile conditions for subsequent patients. Facilities must adhere to the manufacturer’s instructions for proper disposal after use.

What type of environment is this device intended for, and are there any restrictions on its use?

This device is intended for use in non-MRI environments, meaning it should not be operated near magnetic resonance imaging machines. It is also designed for non-critical care settings, such as hemodialysis units, where trained medical personnel can operate it to monitor hemodialysis patients. The manufacturer’s instructions for use outline any additional environmental or operational restrictions.

How is the device supplied, and what does that mean for storage and handling?

The Transonic Hemodialysis Monitor, Cardiac Output (Model HD01-CO) is supplied sterile, which means it is pre-packaged and ready for immediate use without additional sterilization. This requires careful handling to maintain sterility until deployment. Storage should follow the manufacturer’s guidelines to preserve the device’s integrity, typically involving protection from physical damage, extreme temperatures, and contamination until use.

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: Transonic Hemodialysis Monitor, Cardiac Output, Model Hd01-co (K980906 ..., transonic hemodialysis monitor cardiac output model hd01-co, Transonic Systems HD01 Flow-QC Hemodialysis Monitor - ArtisanTG™

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Transonic Systems Inc.
FDA Applicant
Transonic Systems, Inc.

Sources (1)

  • FDA 510(k) K980906 24 fields · synced Oct 6, 2026