Vivus 50 and Vivus 100 Personal Infuser

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K915646 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What is the Vivus 50 and Vivus 100 Personal Infuser used for?

  The Vivus 50 and Vivus 100 Personal Infuser is a Class II medical device designed for personal use in infusion therapy applications. It is intended to deliver fluids or medications through infusion therapy for patients who require this treatment at home or in non-clinical settings.

• How is the Vivus Personal Infuser supplied and is it single-use or reusable?

  The device is available in two models: Vivus 50 and Vivus 100. The device data does not specify whether it is single-use or reusable, nor does it provide information about packaging or supply details. Users should consult the manufacturer's instructions for specific information about device preparation, use, and disposal.

• What are the regulatory approvals for the Vivus Personal Infuser?

  The Vivus 50 and Vivus 100 Personal Infuser received FDA 510(k) clearance with K number K915646 on June 15, 1992. It is classified as a Class II medical device and is regulated under product code FRN and regulation number 880.5725. The device was found to be substantially equivalent to other legally marketed devices.

• Are there different sizes or models available for the Vivus Personal Infuser?

  Yes, the Vivus Personal Infuser is available in two models: Vivus 50 and Vivus 100. These models may have different specifications or capacities, but the device data does not provide specific details about the differences between the models or any size variations within each model.