# K101487: Cheetah Nicom System

- Pathway: 510(k) (Abbreviated)
- Applicant: Cheetah Medical, Inc.
- Decided: Jul 2, 2010 after 35 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: 7 generations back to K903134 (1991). 13 ancestors in all.
35 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071631: Nicom Electrodes, Cheetah Medical, Inc. (2008) Summary page 1.
- K083093: Cheetah Reliant, Cheetah Medical, Inc. (2008). Our reading of the summary gave K082093, FDA’s number for Bullseye Biliary Stent System (Squareone). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cheetah Reliant”. Summary page 1.

## Most influential descendants
- 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
- K213682: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote (2022), 14 descendants of its own

## Indications for use
The Cheetah Reliant with NIBP functionality is a portable, non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean). In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Cheetah Reliant. These parameters are: Cardiac Index (CI), Ventricular Ejection Time (VET), Total Peripheral Resistance Index (TPRI), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Cardiac Power (CP), Cardiac Power Index (CPI) and Thoracic Fluid Content (TEC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care. The alternative NICOM Sensors are disposable electrodes, used in conjunction with the Cheetah Medical NICOM signal processing product line.

Source page: https://510kreport.com/device/K101487
Methodology: https://510kreport.com/methodology