# K112432: Zoll X Series

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corporation, World Wide Headquarters
- Decided: Mar 21, 2012 after 211 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962603 (1997). 81 ancestors in all.
8 later devices descend from it; 3 cite it directly.
2 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102468: Zoll Propaq MD, Zoll Medical Corporation, World Wide Headquarters (2010) Summary page 6.
- K072923: Zoll E Series Defibrillator, Zoll Medical Corporation, World Wide Headquarters (2008) Summary page 6.
- K110168: Zoll E Series with 2010 Aha Guidlines Software Update, Zoll Medical Corporation, World Wide Headquarters (2011) Summary page 6.
- K070455: Zoll E Series with See-Thru CPR, Zoll Medical Corporation, World Wide Headquarters (2007) Summary page 6.
- K032145: Audicor Upgrade System, Inovise Medical, Inc. (2003) Summary page 6.
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter, Masimo Corporation (2010) Summary page 6.
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module, Oridion Capnography, Inc. (2010) Summary page 6.

## Most influential descendants
- K133269: Zoll X Series (2014), 4 descendants of its own
- K121367: Zoll Propaq XM (2012), 3 descendants of its own
- K180482: ZOLL Propaq M (2018), 2 descendants of its own
- K141774: Zoll X Series (2014), 2 descendants of its own
- K202375: ZOLL Propaq M (2021), 1 descendant 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
- Aug 16, 2012 · Class II · Z-2401-2012: Shipped with incorrect software

## Indications for use
The X Series 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 X Series. The X Series 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 X Series 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 X Series 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. 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 X Series 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) X Series 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 X Series 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. Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section "EGG Analysis Algorithm Accuracy" on page A-33. When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight. ECG Monitoring The X Series is intended for use to monitor and/or record 3-, 5-, or 12-lead EGG 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. CPR Monitoring The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age. External Transcutaneous Pacing This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: * Resuscitation from standstill or bradycardia of any etiology: * As a standby when standstill or bradycardia might be expected: * Suppression of tachycardia. * Pediatric pacing. Non-invasive Blood Pressure Monitoring The X Series 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 X Series 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 X Series 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 X Series 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. CO2 Monitoring The X Series 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 X Series 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 as consideration of all other relevant patient data. The 12-lead EGG Analysis is intended for use on adults (> 18 years of age).

Source page: https://510kreport.com/device/K112432
Methodology: https://510kreport.com/methodology