# K253417: Masimo Root Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Aug 12, 2026 after 315 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: 21 generations back to K962603 (1997). 98 ancestors in all.
No later device cites it as a predicate yet.
2 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191882: Masimo Centroid System, Masimo Corporation (2020) Summary page 7.
- K163334: LiDCOunity v2 Hemodynamic Monitor, Lidco, Ltd. (2017) Summary page 7.

## 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 Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital- type facilities, home environments, and transport within healthcare facilities. The Radius-7 Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radius and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, 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 CO2: CO2 ISA AX+: CO2, N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA OR+: CO2, 02, N20, 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 CO2 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 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 The optional Centroid System is intended for monitoring the orientation and activity of patients. The Centroid System is intended to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. The Centroid System is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers. The Centroid System is intended for use in hospitals, hospital-type facilities, and healthcare facilities. The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments. The LIDCO Module is intended for adult patients requiring cardiovascular monitoring who have peripheral arterial pressure monitoring in hospital and hospital-type settings. The LIDCO Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients. It digitizes, analyses & transfers the hemodynamic parameters derived from the analog signal obtained from vital signs monitor to a host device (e.g. Root) for display. In addition to arterial blood pressure parameters (Sys, MAP, Dia) and cardiac output, the LIDCO Module calculates a number of derived parameters: Oxygen Delivery and Oxygen Delivery Index, Oxygen Consumption and Oxygen Consumption Index, Cardiac Index, Stroke Volume and Stroke Volume Index, Heart Rate, Systemic Vascular Resistance and Systemic Vascular Resistance Index, Stroke Volume Variation %, Pulse Pressure Variation % and Body Surface Area

Source page: https://510kreport.com/device/K253417
Methodology: https://510kreport.com/methodology