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Interflo Medical Model INTERFLO/1 Cardiac Output

by Biometric Research Institute, Inc.

510(k) K902628

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902628 Date25 Feb 1991ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1310-06 FDA Unclassified (pre-2012) initiated 21 Jun 2006 on shared 510(k) K902628

    Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in overheating and thermal damage to the CCO catheter and serious patient injury.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Interflo Medical Model Interflo/1 Cardiac Output is a computer, diagnostic, pre-programmed, single-function device used for measuring cardiac output. It is designed to provide accurate cardiac output measurements in clinical settings.

The device is supplied by Biometric Research Institute, Inc. and is FDA 510(k) cleared with K number K902628. It is a class II medical device with product code DXG, intended for cardiovascular applications. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

Other devices from Biometric Research Institute, Inc.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Interflo/1 Cardiac Output device used for?

    The Interflo/1 Cardiac Output is a computer, diagnostic, pre-programmed, single-function device specifically designed for measuring cardiac output in clinical settings to provide accurate cardiovascular assessments.

  • Is the Interflo/1 Cardiac Output device single-use or reusable?

    The device data does not specify whether the Interflo/1 Cardiac Output is intended for single-use or reusable applications, so this information should be confirmed with the manufacturer directly.

  • What regulatory approvals does the Interflo/1 Cardiac Output device have?

    The Interflo/1 Cardiac Output device is FDA 510(k) cleared with K number K902628, classified as a class II medical device with product code DXG, and intended for cardiovascular applications.

  • Who manufactures the Interflo/1 Cardiac Output device?

    The Interflo/1 Cardiac Output device is manufactured by Biometric Research Institute, Inc., located at 1401 Wilson Blvd., Suite 400, Arlington, VA 22209.