# K060559: Zoll R Series Defibrillator

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Aug 17, 2006 after 168 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: 7 generations back to K962603 (1997). 21 ancestors in all.
21 later devices descend from it; 5 cite it directly.
1 of 43 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 2.
- K041892: Zoll Aed Pro External Defibrillator, ZOLL Medical Corporation (2005) Summary page 2.

## Most influential descendants
- K100654: Zoll Propaq MD (2010), 11 descendants of its own
- K110742: Onestep Adult Multi-Function Electrode (2011), 9 descendants of its own
- K102468: Zoll Propaq MD (2010), 9 descendants of its own
- K112432: Zoll X Series (2012), 8 descendants of its own
- K081828: Zoll R Series BLS Defibrillator (2008), 8 descendants of its own

## Recalls of this device
- Aug 31, 2009 · Not classified · Z-2315-2009: Failure of Device to display ECG could delay delivery of defibrillation or pacing therapy.

## 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 oris ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion appropriate. The advisory function should be used to confirm ventricular fibrillation and 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 EGG rhythm analysis function are provided in the section, "EGG Rhythm Analysis Algoirhtm Accuracey" on page A-26. When the patient is less than 8 years of age or weighs less than 55 lbs (25 Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight. Intended-Use - IEGG Monitoring The unit is intended for use when EGG monitoring is indicated to evaluate the patient's heart rate or EGG 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 othier physician-authorized emergency medical training. Intended-Use - GPR Monitoring The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHAJERC 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 CPA 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 endlocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology: INoninvasive 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 endlocardial 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 331b. (15kg) or less using ZOLL pediatric hands-free therapy electrode pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended. Intended-Use - SP0 2 Monitoring The R Series pulse oximeter, with the Masimo® SET® technology and the LNOP® series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SP0 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.

Source page: https://510kreport.com/device/K060559
Methodology: https://510kreport.com/methodology