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Cardiox Flow Detection System

by Cardiox Corp.

510(k) K122400

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

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 NumberK122400 Date5 Nov 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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, 23 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 Cardiox Flow Detection System is a pre-programmed, single-function diagnostic computer used to provide a fluorescent ICG indicator dye dilution curve for cardiac output. It is intended for use in patients with known or suspected circulatory pathway abnormalities.

This device is identified under FDA regulation number 870.1435 and has received FDA 510(k) clearance. It is classified as a class 2 medical device within the cardiovascular specialty.

Questions

AI-generated answers, 23 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 primary function of the Cardiox Flow Detection System?

    This device is a pre-programmed, single-function diagnostic computer designed to provide a fluorescent ICG indicator dye dilution curve to measure cardiac output.

  • Which patients are indicated for use with this system?

    The system is intended for use in patients who have known or suspected abnormalities within their circulatory pathways.

  • What is the regulatory status of this device?

    The Cardiox Flow Detection System is a class 2 medical device that has received FDA 510(k) clearance under regulation number 870.1435.