# K140188: Masimo Root Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jun 25, 2014 after 152 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K962603 (1997). 76 ancestors in all.
58 later devices descend from it; 2 cite it directly.
1 of 135 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121013: Connex Vital Signs Monitor 6000 Series, Welch Allyn, Inc. (2012) Summary page 1.
- K110028: Masimo Radical Y Pulse CO-Oximeter, Masimo Corporation (2011) Summary page 3.
- K103604: Isa CO2, Isa AX+, Isa or+, Phasein AB (2011) Summary page 1.
- K051874: Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose Set, Physiometrix, Inc. (2005) Summary page 1.

## Most influential descendants
- K142394: Masimo Root Monitoring System and Accesories (2014), 51 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K150314: Masimo MightySat Rx Fingertip Pulse Oximeter (2015), 24 descendants of its own
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter (2019), 23 descendants of its own
- K171121: Masimo Root Monitoring System and Accessories (2017), 16 descendants of its own

## Indications for use
The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station). The optional Masimo Radical 7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhernoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SPO2) and pulse rate to multi-parameter devices for the display of those devices. The optional ISA product family consists of three types of sidestreamn gas analyzers (ISA C02, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases: ISA C02: CO2 ISA AX+: C02, N2 0, Halothane, Isaflurane, Enflurane, Sevoflurane and Desfiurane ISA OR+: COL, 02, N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desfiurane ISA C02, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA C02 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients. The optional SEDLine Sedation Monitor is indicated for use in the operating roam (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

Source page: https://510kreport.com/device/K140188
Methodology: https://510kreport.com/methodology