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IVAC 280 Volumetric Infusion Controller

by Y 510(k)

Active United States

510(k) K842419

Overview

The IVAC 280 Volumetric Infusion Controller is an electronic device designed for the control of intravascular infusion. It is classified as a Controller, Infusion, Intravascular, Electronic under FDA product code LDR and is intended for general hospital use.

This device is supplied as a reusable electronic controller and is regulated as a Class II medical device under 21 CFR 880.5725. It received FDA 510(k) clearance (K842419) on August 7, 1984, and is subject to special controls. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842419 Date7 Aug 1984ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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 280 Volumetric Infusion Controller used for?

    The IVAC 280 Volumetric Infusion Controller is designed for the control of intravascular infusion, meaning it regulates the rate and volume of fluids delivered into a patient's bloodstream during general hospital use.

  • Is the IVAC 280 Volumetric Infusion Controller reusable or single-use?

    The device is supplied as a reusable electronic controller, indicating it is intended for multiple uses after appropriate cleaning and maintenance, not as a single-use disposable product.

  • What type of device is the IVAC 280 Volumetric Infusion Controller classified as?

    It is classified as a Controller, Infusion, Intravascular, Electronic under FDA product code LDR and falls under the regulatory category for general hospital use devices.