# K121367: Zoll Propaq XM

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Jun 21, 2012 after 45 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962603 (1997). 82 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112432: Zoll X Series, Zoll Medical Corporation, World Wide Headquarters (2012) Summary page 2.

## Most influential descendants
- K180482: ZOLL Propaq M (2018), 2 descendants of its own
- K202375: ZOLL Propaq M (2021), 1 descendant of its own
- K233354: WVSM Pro (Series) (500-0030-XX) (2024), 0 descendants of its own

## Recalls of this device
- Mar 5, 2014 · Class II · Z-1311-2014: Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used

## Indications for use
Propaq XM Indications For Use The Propaq XM is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, and the use of the Propaq XM. The Propaq XM is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq XM will be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propaq XM unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with. and without heart dysfunction. Pediatric Patient Subpopulation 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 to 21 years of age. ECG Monitoring The Propaq XM is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction. Non-Invasive Blood Pressure Monitoring The Propaq XM is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg. The patient population will range from newborn (neonate) to adult. Temperature Monitoring The Propaq XMV is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user. The patient population will range from newborn (neonate) to adult. SpO2 Monitoring The Propaq XMV pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation, (SpMet). The pulse CO-oximeter and accessories are indicated for use on 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, or in mobile environments. Respiration Monitoring The Propaq XMV is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. The patient population will range from newborn (neonate) to adult. C02 Monitoring The Propaq XMV is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate. The patient population will range from newborn (neonate) to adult. Invasive Pressure Monitoring The Propaq XM is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply. The patient population will range from newborn (neonate) to adult. 12-Lead Analysis The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting EG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of EGG data offered by the device are only significant when used in conjunction with caregiver overread as well s consideration of all other relevant patient data. The 12-lead ECG Anal is isitend d for use on adults (> 18 years of age).

Source page: https://510kreport.com/device/K121367
Methodology: https://510kreport.com/methodology