# K112761: Zoll Propaq MD

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corporation, World Wide Headquarters
- Decided: Apr 25, 2012 after 216 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- 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: 10 generations back to K962603 (1997). 62 ancestors in all.
No later device cites it as a predicate yet.
2 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100654: Zoll Propaq MD, Zoll Medical Corporation, World Wide Headquarters (2010) Summary page 2.
- K072923: Zoll E Series Defibrillator, Zoll Medical Corporation, World Wide Headquarters (2008) Summary page 6.
- K032145: Audicor Upgrade System, Inovise Medical, Inc. (2003) Summary page 6.

## 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
The Propaq MID is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care and the use of the Propaq MD. The Propaq MID 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 MID will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propaq MD 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 Subpopulation Approx. 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 When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.), use ZOLL pedi-padz@ pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight. Manual Defibrillation Use of the Propaq MID in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: * Unconsciousness * Absence of breathing * Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate. The patient population will range from newborn (neonate) to adult. Semiautomatic Operation (AED) The Propaq MVD products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the Propacj MVD in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: *Unconsciousness. *Absence of breathing. *Absence of pulse. When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight. EGG Monitoring The Propaq MVD is intended for use to monitor and/or record 3, 5,12-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. External Transcutaneous Pacing This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endlocardial stimulation. The purposesof pacing include: *Resuscitation from standstill or bradycardia of any etiology: Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug induced standstill (due to procainamide, quinidline, digitalis, b-blockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes. As a standby when standstill or bradycardia might be expected: Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing may provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endlocardial pacing. *Suppression of tachycardia: Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia. *Pediatric Pacing: Pacing can be performed on pediatric patients weighing 33 lbs. (15kg) or less using ZOLL pediatric hands-free therapy electrode pads. Prolonged pacing (in excess of 30 minutes), piarticularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended. Non-Invasive Blood Pressure Monitoring The Propaq MD 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 patients arm or leg. The patient population will range from newborn (neonate) to adult. Temperature Monitoring The Propaq MID 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. 5p02 Monitoring The Propaq MID is intended for use to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. The patient population will range from newborn (neonate) to adult. Respiration Monitoring The Propaq MID 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 MID is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. The patient population will range from newborn (neonate) to adult. Invasive Pressure Monitoring The Propaq MVD 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 contra-indications 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 ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data. The 12-lead ECG Analysis is intended for use on adults (> 18 years of age).

Source page: https://510kreport.com/device/K112761
Methodology: https://510kreport.com/methodology