# K180482: ZOLL Propaq M

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Nov 30, 2018 after 280 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962603 (1997). 83 ancestors in all.
2 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)
- K121367: Zoll Propaq XM, ZOLL Medical Corporation (2012) Summary page 6.

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

## Indications for use
Electrocardiogram (ECG) Monitoring The Propaq M system is indicated to monitor and/or record 3-, 5-, or 12-lead electrocardiogram (ECG) waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. ECG monitoring is indicated for patients from newborn (neonate) to adult, with and without heart dysfunction. Non-Invasive Blood Pressure Monitoring The Propaq M system is indicated 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. The non-invasive blood pressure monitoring feature is indicated for patients from newborn (neonate) to adult. Temperature Monitoring The Propaq M system is indicated 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 temperature monitoring feature is indicated for use in patients from newborn (neonate) to adult. SpO2 Monitoring The Propaq M system is indicated for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), pleth variability index (PVI), and perfusion index (PI) via the pulse Co-oximeter and accessories. 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 M system is indicated 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 respiration monitoring feature is indicated for use on patients from newborn (neonate) to adult. CO2 Monitoring The Propaq M system is indicated for use in continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate. The CO2 monitoring feature is indicated for use on patients from newborn (neonate) to adult. Invasive Pressure Monitoring The Propaq M system is indicated for use to display and make continuous invasive pressure measurements via a compatible pressure transducer. The invasive pressure monitoring feature is indicated for use on patients from newborn (neonate) to adult. 12-Lead Analysis The Propaq M system is indicated for use in acquiring, analyzing and reporting physiological data via 12-lead ECG Analysis, and to provide interpretation of the data for consideration by caregivers. The 12-lead ECG Analysis feature is indicated for use on adults (> 18 years of age). Web Console The Propaq M system is indicated for the remote display of physiological data displayed on connected Propaq M systems via the Web Console feature, including electrocardiogram (ECG), non-invasive blood pressure (NIBP), temperature, and heart rate. Mobile Streaming The Propaq M Mobile Streaming Client Application is intended for use by trained medical personnel familiar with basic monitoring, vital sign assessment, and emergency cardiac care in order to remotely view near real-time patient and device data transmitted from connected Propaq M devices. It requires a clinician at the patient’s side next to the Propaq M device. The information streamed to the client application helps the remote clinician make decisions on patient care supplemental to the clinician on site with the patient. Important: The remote clinician should not use Mobile Streaming as a primary diagnostic device, but instead use the data to consult with the clinician at the patient side.

Source page: https://510kreport.com/device/K180482
Methodology: https://510kreport.com/methodology