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IVAC Controlled Release Infusion System

by Y 510(k)

Active United States

510(k) K854574

Overview

The IVAC Controlled Release Infusion System is a medical device designed for controlled release infusion. It is categorized under product code FPA and is intended for use in hospital settings.

The device is supplied by Y and is authorized under FDA 510K clearance with K-number K854574. It is manufactured in San Diego, CA, and is intended for single-use or reusable applications as specified by the manufacturer.

AI-generated from registry data, 23 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 NumberK854574 Date23 Jan 1986ClearedStatusActive

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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Y

See all devices from Y →

Questions

  • What is the IVAC Controlled Release Infusion System used for?

    The IVAC Controlled Release Infusion System is a medical device designed for controlled release infusion in hospital settings. It is categorized under product code FPA and is intended for various infusion applications as specified by the manufacturer.

  • Is the IVAC Controlled Release Infusion System single-use or reusable?

    The IVAC Controlled Release Infusion System can be either single-use or reusable depending on the specifications provided by the manufacturer, Y. The specific usage instructions would be detailed in the product documentation.

  • What regulatory approvals does the IVAC Controlled Release Infusion System have?

    The IVAC Controlled Release Infusion System is authorized under FDA 510K clearance with K-number K854574. It was manufactured in San Diego, CA and received FDA clearance on January 23, 1986.

  • Who manufactures the IVAC Controlled Release Infusion System?

    The IVAC Controlled Release Infusion System is manufactured by Y, with its manufacturing facility located in San Diego, CA. The company can be contacted through Robert J Bard at their P.O. Box 85335 address.