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Belmont Rapid Infuser

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141654

by Belmont Instrument Corporation

Identifiers

510(k) Number
K141654 FDA 510(k)
FDA Product Code
FRN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Belmont Rapid Infuser is a pump and infusion device designed for the rapid delivery of warmed blood and fluids. It automatically and continuously monitors both the infusion process and device operation, with alarms that identify unsafe conditions and a touch screen that displays solutions to problems.

This device is intended for use in general hospital settings and is supplied as a single-use or reusable product. It is MRI safe and available in various sizes. The Belmont Rapid Infuser has FDA 510K clearance with product code FRN and is regulated under number 880.5725.

Frequently asked questions

What is the Belmont Rapid Infuser used for?

The Belmont Rapid Infuser is a pump and infusion device designed for the rapid delivery of warmed blood and fluids in general hospital settings. It automatically monitors the infusion process and device operation with alarms for unsafe conditions.

Is the Belmont Rapid Infuser single-use or reusable?

The Belmont Rapid Infuser is supplied as either a single-use or reusable product, depending on the specific configuration selected for clinical needs.

What are the regulatory specifications for the Belmont Rapid Infuser?

The Belmont Rapid Infuser has FDA 510K clearance with product code FRN and is regulated under number 880.5725. It is classified as a Class II device and is MRI safe.

How is the Belmont Rapid Infuser supplied?

The Belmont Rapid Infuser is available in various sizes to accommodate different clinical requirements and is designed for use in general hospital settings.

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: Rapid Infuser (RI-2) - Blood/IV Infusion Pump | Belmont Medical, BELMONT RI-2 OPERATOR'S MANUAL Pdf Download | ManualsLib, PDF Belmont Rapid Infuser - resuspro.com, RI-2 - Volumetric infusion pump by Belmont Medical Technologies ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Belmont Instrument Corporation

Sources (1)

  • FDA 510(k) K141654 24 fields · synced Oct 6, 2026