# K120907: Zoll R Series

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corporation, World Wide Headquarters
- Decided: Sep 25, 2012 after 183 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962603 (1997). 35 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 42 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110361: Zoll R Series with 2010 Aha Guidelines Software Update, Zoll Medical Corporation, World Wide Headquarters (2011) Summary page 5.
- K111594: Zoll E Series, Zoll Medical Corporation, World Wide Headquarters (2011) Summary page 5.
- K110978: Onestep Pediatric Mfe's, ZOLL Medical Corporation (2011) Summary page 5.
- K110742: Onestep Adult Multi-Function Electrode, ZOLL Medical Corporation (2011) Summary page 5.

## Most influential descendants
- K133269: Zoll X Series (2014), 4 descendants of its own
- K141774: Zoll X Series (2014), 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
- K150055: OneStep Pediatric CPR Multi-Function Electrode (2015), 0 descendants of its own

## Indications for use
Defibrillator Function Intended Use - Manual Operation Use of the R Series products in the manual 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. 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. In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate. The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above). Intended Use - Semiautomatic Operation (AED) R 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 R 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 EGG rhythm analysis function are provided in the section, "EGG Rhythm Analysis Algorithm Accuracy" on page A-29. 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 patients exact age or weight. Intended Use - ECG Monitoring. The unit is intended for use when EGG monitoring is indicated to evaluate the patient's heart rate or EGG morphology. In EGG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the RSeries defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training. Intended Use - Real CPR Help The Real CPR Help 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 compression depth in accordance with AHA and/or FRC recommendations of 2 inches (5cm) minimum for adult patients. External Pacemaker (Optional) Intended Use - Pacemaker 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. Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug-induced standstill (due to procainamide, quinidine, 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 endlocardial or other temporary electrodes. * As a standby when standstill or bradycardia might be expected. Noninvasive pacing can 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. Instandby pacing applications, noninvasive pacing might 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 endocardial pacing. * Suppression of tachycardia. Increased headt rates in response to external pacing often suppress ventricular ectopic activity and might prevent tachycardia. Pediatric Pacing Pacing can be performed on pediatric patients weighing 33 lb. (15 kg) or less using ZOLL pediatric hands-free therapy electrodes. Prolonged pacing (inexcess of 30 minutes), particularly in neonates, can cause burns. Periodic inspection of the underlying skin is recommended. intended Use - SpO2 Monitoring The RSeries pulse oximeter, with the Masimo@ SET@ technology and the LNCS@ series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO 2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or prehospital environment. Intended Use - EtCO2 Monitoring The ZOLL R Series EtCO2 option with Respironics Novametrix technology is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia. This option uses the CAPNOSTAT 5 Mainstream C02 sensor attached to an airway adapter that connects to an endotracheal tube, mask or disposable mouthpiece. The R Series EtCO2 option is designed to monitor adult, pediatric. and neonatal patients. The following substances can influence C02 measurements made with the CAPNOSTAT 5 C02 sensor: elevated oxygen levels nitrous oxide halogenated agents The R Series EtCO2 option provides settings for high oxygen and/or nitrous oxide compensation. Halogenated anesthetic agents alter C02 readings, but the RSeries unit will monitor C02 within specifications when these agents are present at normal clinical levels. The presence of Desflurane in the exhaled breath beyond normal values (5%) may positively bias measured carbon dioxide values by up to an additional 3 mmHg. The R Series EtCO2 option is intended for use only with the ZOLL/Respironics Novametrix CAPNOSTAT 5 Mainstream C02 Sensor and mainstream airway adapters. The R Series EtCO2 option can be used on adult patients (21 years of age and older) and on pediatric patients, as described in the following table: Pediatric 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 12-21 years of age Intended Use - NIBP The ZOLL R Series NIBP option is indicated for the non-invasive measurement of arterial blood pressure for resting patients in critical care and in-hospital transport. The R Series NIBP option is designed to measure blood pressure for adult patients (21 years of age and older) and for pediatric patients, as described in the following table: Pediatric Subpopulation Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2years of age Child 2 to 12 years of age Adolescent T12-1 years of age

Source page: https://510kreport.com/device/K120907
Methodology: https://510kreport.com/methodology