# K171121: Masimo Root Monitoring System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Nov 17, 2017 after 214 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: 19 generations back to K962603 (1997). 90 ancestors in all.
16 later devices descend from it; 5 cite it directly.
2 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151644: Masimo Root Vital Signs Monitoring System and Accessories, Masimo Corporation (2016) Summary page 5.

## Most influential descendants
- K193242: Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories (2020), 7 descendants of its own
- K191882: Masimo Centroid System (2020), 3 descendants of its own
- K230626: Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ (2023), 2 descendants of its own
- K223498: Radius VSM and Accessories (2023), 1 descendant of its own
- K201770: Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor (2020), 1 descendant of its own

## Indications for use
The Masimo Root Monitoring System and Accessories are indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. The Masimo Root Monitoring System and Accessories can communicate with network systems 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, carboxyhemoglobin 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 Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp0O2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities. The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+) and accessories including Nomoline, intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases: ISA CO2: CO; ISA AX+: CO2, N>O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA OR+: CO2, Oz, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA CO2, 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 CO?2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric, infant and neonatal patients. The optional SEDLine Sedation Monitor is indicated for use in the operating room (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. The optional temperature module is indicated to measure temperature (oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider. The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table: Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older

Source page: https://510kreport.com/device/K171121
Methodology: https://510kreport.com/methodology