Skip to content

IVAC Flow Control Administration Set

by Y 510(k)

Active United States

510(k) K870132

Overview

The IVAC Flow Control Administration Set is a Controller, Infusion, Intravascular, Electronic device designed for regulating the flow of intravenous fluids. It is classified as a Class II medical device under product code LDR with special controls.

This device is supplied by Y and is intended for use in general hospital settings. The IVAC Flow Control Administration Set received FDA 510(k) clearance on February 5, 1987, with the decision code SESE (Substantially Equivalent). It is regulated under number 880.5725 and is not a third-party reviewed device.

AI-generated from registry data, 27 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 NumberK870132 Date5 Feb 1987ClearedStatusActive

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
  • 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

Other devices from Y

See all devices from Y →

Questions

  • What is the IVAC Flow Control Administration Set used for?

    The IVAC Flow Control Administration Set is an electronic device designed for regulating the flow of intravenous fluids in general hospital settings. It functions as a controller for intravascular infusion therapy.

  • How is the IVAC Flow Control Administration Set supplied?

    The device is supplied by manufacturer Y and is intended for use in general hospital settings. It is classified as a Class II medical device under product code LDR with special controls.

  • What is the regulatory status of the IVAC Flow Control Administration Set?

    The IVAC Flow Control Administration Set received FDA 510(k) clearance on February 5, 1987, with the decision code SESE (Substantially Equivalent). It is regulated under number 880.5725 and is not a third-party reviewed device.

  • Is the IVAC Flow Control Administration Set reusable or single-use?

    The device data does not specify whether the IVAC Flow Control Administration Set is designed for single-use or reuse. This information would need to be obtained directly from the manufacturer Y or through the product's instructions for use.