# K021174: Ecom Endotrachial Cardiac Output Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Surgical
- Decided: Apr 29, 2003 after 382 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: 2 generations back to K851426 (1985). 7 ancestors in all.
12 later devices descend from it; 1 cites 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)
- K972798: Dynemo 3000, Sometec, Inc. (1998) Summary page 2.
- K963183: Bioz System, Cardiodynamics International Corp. (1996) Summary page 2.
- K934742: Swan-Ganz Continuous Cardiac Output/Oximetry/Venous Port, Baxter Healthcare Corp (1994) Summary page 2.
- K870857: Abcom 1 Cardiac Output Monitor, Applied Biometrics, Inc. (1987) Summary page 2.
- (no number) Hemosonic: named in the summary without a submission number

## Most influential descendants
- K032491: Ecom CV4 Endotracheal Cardiac Output Monitor (2003), 11 descendants of its own
- 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

## Indications for use
The ECOM (Endotracheal Cardiac Output Monitoring) 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 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/K021174
Methodology: https://510kreport.com/methodology