Prismacomfort Autocontrol 3XPT with Autoline XPT 4R
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071909 FDA 510(k)
- FDA Product Code
- KOC 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 Prismacomfort Autocontrol 3XPT with Autoline XPT 4R is a blood circuit accessory designed for hemodialysis. It functions as a blood warmer, maintaining patient temperature during Prismaflex treatments by heating the return blood flow lines to prevent hypothermia. The device integrates a controller and a silicone sleeve warmer that wraps around the blood return line, using resistive heating to transfer warmth directly to the blood.
This system is supplied as a reusable medical device, intended for use with the Prismaflex CFM hemodialysis machine. The Autoline XPT 4R sleeve warmer features a 6.55 mm diameter silicone tube with a specified length, while the Autocontrol 3XPT includes mounting hardware for secure attachment to the Prismaflex device. It has received FDA 510(k) clearance under the classification of Class II medical devices, adhering to regulatory standards for hemodialysis accessories. Storage and handling follow manufacturer guidelines to ensure sterility and functionality.
Frequently asked questions
What is the Prismacomfort Autocontrol 3XPT with Autoline XPT 4R used for?
This device is designed as a blood circuit accessory for hemodialysis, specifically to prevent hypothermia during Prismaflex treatments. It achieves this by heating the return blood flow lines using a silicone sleeve warmer with resistive heating, ensuring patient temperature stability throughout the procedure.
How is the Prismacomfort Autocontrol 3XPT with Autoline XPT 4R supplied and intended for use?
The device is supplied as a reusable medical accessory and is intended exclusively for use with the Prismaflex CFM hemodialysis machine. It includes a controller and a silicone sleeve warmer (Autoline XPT 4R) that wraps around the blood return line, along with mounting hardware for secure attachment to the Prismaflex device.
What are the key specifications of the Autoline XPT 4R silicone sleeve warmer?
The Autoline XPT 4R features a silicone tube with a diameter of 6.55 mm. The length of the tube is not specified in the provided data, but it is designed to fit and wrap securely around the blood return line to facilitate direct heat transfer to the blood during hemodialysis.
Is the Prismacomfort Autocontrol 3XPT with Autoline XPT 4R sterile upon delivery?
The device is not explicitly stated to be sterile upon delivery in the provided data. However, it is a reusable medical device, so sterility must be maintained through proper cleaning, disinfection, and storage procedures as outlined by the manufacturer to ensure safe and effective use.
How should the Prismacomfort Autocontrol 3XPT with Autoline XPT 4R be stored and handled?
Storage and handling instructions are provided by the manufacturer to ensure sterility and functionality. While specific details are not included in the data, reusable medical devices like this typically require cleaning, disinfection, and proper storage in a clean, dry environment to prevent contamination and maintain performance.
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: Prismacomfort, Model Autocontrol 3xpt With Autoline Xpt 4r (K071909 ..., BARKEY PRISMACOMFORT MANUAL Pdf Download | ManualsLib, BARKEY PRISMACOMFORT INSTRUCTION MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071909 | Class II | Active |
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Manufacturer
- Manufacturer
- Barkey GmbH & Co. KG
Sources (1)
- FDA 510(k) K071909 24 fields · synced Oct 1, 2026