# K122400: Cardiox Flow Detection System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiox Corp.
- Decided: Nov 5, 2013 after 455 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Nihon Kohden MLC-4200 Cardiac Output Computer: named in the summary without a submission number
- (no number) Nihon Kohden MLC-4100 Cardiac Output Computer: named in the summary without a submission number

## Indications for use
The Cardiox Flow Detection System Model 99 provides a fluorescent ICG indicator dye dilution curve for cardiac output in patients with known or suspected circulatory pathway abnormalities. The system is not designed to produce a definitive interpretation or exhaustive evaluation of a patient's circulatory pathway. Rather, it is intended to be used as a support tool in conjunction with other clinical and diagnostic findings. This device is only intended for use on patients that weigh more than 10kg.

Source page: https://510kreport.com/device/K122400
Methodology: https://510kreport.com/methodology