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Continuous Cardiac Output System

by Abbott Laboratories 510(k)

Active United States

510(k) K932414

Overview

A continuous cardiac output system is a computer-based diagnostic device that is pre-programmed and single-function, designed to measure cardiac output continuously. It falls under the cardiovascular medical specialty and is classified as a Class II device by the FDA.

The device was submitted for review on May 19, 1993, and received traditional 510(k) clearance on November 14, 1994, under k-number K932414. It is substantially equivalent to a predicate device and is regulated under FDA regulation number 870.1435 with product code DXG.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932414 Date14 Nov 1994ClearedStatusActive

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

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0145-2010 FDA Unclassified (pre-2012) initiated 11 Aug 2009
    • Terminated Z-0147-2010 FDA Unclassified (pre-2012) initiated 11 Aug 2009
    • Terminated Z-0142-2010 FDA Unclassified (pre-2012) initiated 11 Aug 2009
    • Terminated Z-0146-2010 FDA Unclassified (pre-2012) initiated 11 Aug 2009

    Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.

Specification

510(k)

510(k) Number
FDA Product Code
DXG
Device Class
Class II
Regulation
21 CFR Part 870.1435
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Continuous Cardiac Output System used for?

    The Continuous Cardiac Output System is a computer-based diagnostic device designed to measure cardiac output continuously. It is pre-programmed and single-function, meaning it performs only this specific monitoring task within the cardiovascular medical specialty to support clinical assessment of heart function.

  • How is the Continuous Cardiac Output System supplied and is it reusable?

    The device is supplied as a pre-programmed, single-function computer-based system. Based on its classification as a diagnostic device intended for continuous monitoring, it is designed for reuse with appropriate cleaning and maintenance between uses, though specific reprocessing instructions are not detailed in the provided data.

  • What regulatory pathway was used for the Continuous Cardiac Output System?

    The device received traditional 510(k) clearance from the FDA on November 14, 1994, under k-number K932414. It was determined to be substantially equivalent to a predicate device and is regulated under FDA regulation number 870.1435 with product code DXG, placing it in Class II for cardiovascular diagnostic devices.