# K081828: Zoll R Series BLS Defibrillator

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Dec 9, 2008 after 165 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: 8 generations back to K962603 (1997). 22 ancestors in all.
8 later devices descend from it; 1 cites it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060559: Zoll R Series Defibrillator, ZOLL Medical Corporation (2006) Summary page 6.

## Most influential descendants
- K110361: Zoll R Series with 2010 Aha Guidelines Software Update (2011), 7 descendants of its own
- K120907: Zoll R Series (2012), 6 descendants of its own
- 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

## Indications for use
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 ECG rhythm analysis function are provided in this section, "ECG Rhythm Analysis Algorithm Accuracy" on page 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 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. Semiautomatic Operation Contraindications for Use The rhythm analysis function may not reliably identify ventricular fibrillation in the presence of an implanted pacemaker. Inspection of the electrocardiogram and clinical evidence of cardiopulmonary arrest should be the basis for any treatment of patients with implanted pacemakers. Do not use the rhythm analysis function during patient movement on a stretcher or in an ambulance or other conveyance. A patient must be motionless during ECG analysis. Do not touch the patient during analysis. Cease all movement of the stretcher or vehicle prior to analyzing the ECG. If you are using the R Series in an emergency vehicle, bring the vehicle to a halt before activating the analysis function. Defibrillator Complications Inappropriate defibrillation or cardioversion of a patient (for example, with no malignant arrhythmia) may precipitate ventricular fibrillation, asystole, or other dangerous arrhythmias. Defibrillation without proper application of electrodes or paddle electrolyte gel might be ineffective and cause burns, particularly when repeated shocks are necessary. Erythema or hyperemia of the skin under the paddles, or electrodes often occurs; this effect is usually enhanced along the perimeter of the paddles or electrodes. This reddening should diminish substantially within 72 hours. Defibrillator Output Energy R Series defibrillators can deliver as much as 200 joules into a 50 ohm impedance. The energy delivered through the chest wall, however, is determined by the patient's transthoracic impedance. An adequate amount of electrolyte gel must be applied to the paddles and a force of 10 to 12 kilograms (22 to 26.4 pounds) must be applied to each paddle in order to minimize this impedance. If hands-free therapy electrodes are used, make sure that they are properly applied. (Refer to the instructions on the electrode package). External Pacemaker (Optional) Some R Series products include an optional transcutaneous pacemaker consisting of a pulse generator and ECG-sensing circuitry. Noninvasive transcutaneous pacing (NTP) is an established and proven technique. This therapy is easily and rapidly applied in both emergency and nonemergency situations when temporary cardiac stimulation is indicated. The output current of the pacemaker is continuously variable from 0 to 140 mA. The rate is continuously variable from 30 to 180 pulses per minute (ppm), by increments of 2. The pacing output pulse is delivered to the heart via ZOLL hands-free defibrillation/pacing electrodes placed on the patient's back and the precordium. The characteristics of the output pulse, together with the design and placement of the electrodes, minimize cutaneous nerve stimulation, cardiac stimulation threshold currents, and reduce discomfort due to skeletal muscle contraction. The unique design of the R Series BLS products allow clear viewing and interpretation of the electrocardiogram on the display without offset or distortion during external pacing. Proper operation of the device, together with correct electrode placement, is critical to obtaining optimal results. Every operator must be thoroughly familiar with these operating instructions. 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 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. In standby 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 heart rates in response to external pacing often suppress ventricular ectopic activity and might prevent tachycardia. This device can only be used for external pacing of patients and cannot be used for internal pacing. Do not connect internal pacing lead wires to the ZOLL defibrillator. Pacemaker Complications Ventricular fibrillation does not respond to pacing and requires immediate defibrillation. Therefore, the patient's dysrhythmia must be determined immediately, so that you can employ appropriate therapy. If the patient is in ventricular fibrillation and defibrillation is successful but cardiac standstill (asystole) ensues, you should use the pacemaker. Ventricular or supraventricular tachycardias can be interrupted with pacing, but in an emergency or during circulatory collapse, synchronized cardioversion is faster and more certain. Pulseless electrical activity (PEA) can occur following prolonged cardiac arrest or in other disease states with myocardial depression. Pacing might then produce ECG responses without effective mechanical contractions, making other effective treatment necessary. Pacing can evoke undesirable repetitive responses, tachycardia, or fibrillation in the presence of generalized hypoxia, myocardial ischemia, cardiac drug toxicity, electrolyte imbalance, or other cardiac diseases. Pacing by any method tends to inhibit intrinsic rhythmicity. Abrupt cessation of pacing, particularly at rapid rates, can cause ventricular standstill and should be avoided. Noninvasive temporary pacing can cause discomfort of varying intensity, which occasionally can be severe and preclude its continued use in conscious patients. Similarly, unavoidable skeletal muscle contraction might be troublesome in very sick patients and might limit continuous use to a few hours. Erythema or hyperemia of the skin under the hands-free therapy electrodes often occurs; this effect is usually enhanced along the perimeter of the electrode. This reddening should lessen substantially within 72 hours. There have been reports of burns under the anterior electrode when pacing adult patients with severely restricted blood flow to the skin. Prolonged pacing should be avoided in these cases and periodic inspection of the underlying skin is advised. There are reports of transient inhibition of spontaneous respiration in unconscious patients with previously available units when the anterior electrode was placed too low on the abdomen. This device can only be used for external pacing of patients and cannot be used for internal pacing. Do not connect internal pacing lead wires to the ZOLL defibrillator. 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 (in excess of 30 minutes), particularly in neonates, can 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 LNOP® 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 pediaatric and neonatal patients in a hospital or prehospital environment.

Source page: https://510kreport.com/device/K081828
Methodology: https://510kreport.com/methodology