# K131765: Ecom Endotracheal Cardiac Output Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Dec 20, 2013 after 186 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K851426 (1985). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032491: Ecom CV4 Endotracheal Cardiac Output Monitor, Imagyn Medical Technologies, Inc. (2003) Summary page 1.

## Most influential descendants
- K172196: ECOM™ Cardiac Output Monitoring System (2017), 0 descendants of its own

## Indications for use
The ECOM Endotracheal Cardiac Output Monitor System is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an EGOM Endotracheal Tube. The ECOM System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used. The ECOM System will display the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (00), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressure.

Source page: https://510kreport.com/device/K131765
Methodology: https://510kreport.com/methodology