# K071631: Nicom Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Cheetah Medical, Inc.
- Decided: Jan 18, 2008 after 218 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- 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 K000664 (2000). 2 ancestors in all.
36 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000664: Vigilance Cco/Cedv & Vigilance Cco/SVO2/Cedv Monitors, Baxter Healthcare Corp (2000) Summary page 2.
- K042144: NICOM, Cheetah Medical, Inc. (2004) Summary page 2.
- (no number) 3M Health Care Red Dot electrodes: named in the summary without a submission number

## Most influential descendants
- K101487: Cheetah Nicom System (2010), 35 descendants of its own
- K190205: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (2019), 34 descendants of its own
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (2020), 27 descendants of its own
- K203687: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (2021), 18 descendants of its own
- K211465: HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform (2021), 15 descendants of its own

## Indications for use
The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of Ltr/Min, and was cleared under K042144. NICOM Electrodes are disposable electrodes used in conjunction with the NICOM signal processing product line.

Source page: https://510kreport.com/device/K071631
Methodology: https://510kreport.com/methodology