# K172196: ECOM™ Cardiac Output Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ecom Medical, Inc.
- Decided: Sep 19, 2017 after 60 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: 5 generations back to K851426 (1985). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131765: Ecom Endotracheal Cardiac Output Monitor System, Conmed Corporation (2013) Summary page 5.
- K092886: Well Lead Endobronchial Tubes, Well Lead Instruments (2010) Summary page 5.

## Indications for use
The ECOM Cardiac Output Monitoring System is intended for the monitoring of cardiac output by impedance cardiography. The ECOM System displays 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. 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 with the 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 Double Lumen Endobronchial Tube is used to isolate the left lung of a patient for surgery, one lung ventilation or one lung anesthesia. The ECOM Endobronchial Tube is indicated for use in thoracic surgery, bronchspirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. The tube allows isolation and selective insufflation or deflation of either lung.

Source page: https://510kreport.com/device/K172196
Methodology: https://510kreport.com/methodology