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Ivac Site-Saver Volumetric Controller - 280+

by Y 510(k)

Active United States

510(k) K874491

Overview

This device is a Controller, Infusion, Intravascular, Electronic, as defined in the FDA classification system. It is designed to regulate the flow of intravenous fluids with precision in clinical settings.

It is supplied as a reusable electronic controller for intravascular infusion therapy. The device received FDA 510(k) clearance (K874491) on February 25, 1988, and is classified as Class II under product code LDR for general hospital use.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874491 Date25 Feb 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
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  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Ivac(R) Site-Saver(R) Volumetric Controller - 280+
510(k) Number
FDA Product Code
LDR
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the IVAC Site-Saver Volumetric Controller 280+ used for?

    The IVAC Site-Saver Volumetric Controller 280+ is designed to regulate the flow of intravenous fluids with precision in clinical settings. As an electronic intravascular infusion controller, it ensures accurate delivery of IV therapies by controlling flow rates, which is critical for patient safety and treatment efficacy in general hospital environments.

  • Is the IVAC Site-Saver Volumetric Controller 280+ reusable or single-use?

    The IVAC Site-Saver Volumetric Controller 280+ is supplied as a reusable electronic controller for intravascular infusion therapy. This means it is intended for multiple uses after proper cleaning and maintenance between patients, unlike single-use disposable devices, which helps reduce long-term costs in clinical workflows while maintaining performance standards.

  • What regulatory clearance does the IVAC Site-Saver Volumetric Controller 280+ have?

    The IVAC Site-Saver Volumetric Controller 280+ received FDA 510(k) clearance under submission K874491 on February 25, 1988. It was determined to be substantially equivalent to a predicate device and is classified as Class II under product code LDR, which governs controllers for infusion, intravascular, electronic devices for general hospital use.