# K090989: Zoll R Series with Nibp and ETCO2 Options, Zoll R Series

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corp
- Decided: Sep 23, 2009 after 169 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: 7 generations back to K962603 (1997). 18 ancestors in all.
27 later devices descend from it; 2 cite it directly.
1 of 46 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042007: Zoll E Series Defibrillator, Zoll Medical Corp (2005) Summary page 5.

## Most influential descendants
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K171121: Masimo Root Monitoring System and Accessories (2017), 16 descendants of its own
- K170168: Masimo Rad-97 and Accessories (2017), 14 descendants of its own
- K180046: Masimo Rad-97 and Accessories (2018), 13 descendants of its own
- K183697: Masimo Rad-97 and Accessories (2019), 9 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) The 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 ECG rhythm analysis function are provided in the section, "ECG Rhythm Analysis Algorithm Accuracy" on page A-29. When the patient is less than 8 years of age or weighs less than 55lbs (25Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight. Intended Use - ECG Monitoring The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician authorized emergency medical training. Intended Use - 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 compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age. External Pacemaker (Pacer Version Only) 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 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 endocardial 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 33lb. (15kg) or less using ZOLL pediatric hands-free therapy electrodes. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended. Intended Use - SpO2 Monitoring The R Series 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 (SpO2) 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 - NIBP Monitoring 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 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age 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 R Series 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

Source page: https://510kreport.com/device/K090989
Methodology: https://510kreport.com/methodology