# K032491: Ecom CV4 Endotracheal Cardiac Output Monitor

- Pathway: 510(k) (Special)
- Applicant: Imagyn Medical Technologies, Inc.
- Decided: Sep 4, 2003 after 23 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: 3 generations back to K851426 (1985). 8 ancestors in all.
11 later devices descend from it; 2 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021174: Ecom Endotrachial Cardiac Output Monitor, Imagyn Surgical (2003)

## Most influential descendants
- K094054: Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube (2010), 8 descendants of its own
- K110989: Neurovision Ink Printed Endotracheal Tube Electrode (2011), 4 descendants of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own
- K131765: Ecom Endotracheal Cardiac Output Monitor System (2013), 1 descendant of its own
- K112686: Next Gen Emg Endotracheal Tube (2012), 1 descendant of its own

## Indications for use
The ECOM CV4 (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 ECOM 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 CV4 System will display the R-Wave Detection and the Impedance Waveforms as well as the patient’s Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressure.

Source page: https://510kreport.com/device/K032491
Methodology: https://510kreport.com/methodology