# K022004: Cardiac Output Kit, Model CO-1 & Inline Sensor Cable, Model Ils-1

- Pathway: 510(k) (Traditional)
- Applicant: Biosensors International-USA
- Decided: Mar 12, 2003 after 266 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830523 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830523: Catheter Connection W/Integral Injectate, Gould, Inc. (1983) Summary page 1.
- (no number) Becton Dickinson’s sterile, package, disposable SP4572 system: named in the summary without a submission number
- (no number) Becton Dickinson’s CO Set and temperature probe: named in the summary without a submission number

## Indications for use
Biosensors Inline Sensor Assembly is designed for closed injectate delivery system use. It connects to the CVP lumen of a Thermodilution catheter to perform room temperature injections and determine a temperature reading. The inline temperature sensor housing connects to a reusable thermistor cable assembly (the Inline Temperature Assembly) that leads to a Marquette 7000 series Cardiac Output Computer. An inline check valve prevents reflux of fluid andor blood into the system after injections. The intended use of Biosensors Inline Sensor Assembly is identical to that of Becton Dickinson's SP4572 disposable in-line injectate set.

Source page: https://510kreport.com/device/K022004
Methodology: https://510kreport.com/methodology