# K081081: Zoll E Series with Bluetooth Dial UP Networking

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corporation, World Wide Headquarters
- Decided: Mar 9, 2009 after 327 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.
No later device cites it as a predicate yet.
1 of 19 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.

## Indications for use
Defibrillator Function The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. Intended Use - Manual Operation Use of the E 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. Intended Use - Semiautomatic Operation (AED) The E 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. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team. Use of the device 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. Semiautomatic Operation Contraindications for Use The rhythm analysis function may not reliably identify ventricular fibrillation in the presence of an implantable pacemaker. Inspection of the electrocardiogram and clinical evidence of cardiopulmonary arrest should be the basis for any treatment of patients with implantable 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 via stretcher or vehicle prior to analyzing the EGG. If using the device in an emergency vehicle, bring the vehicle to a halt before activating the analysis function. Defibrillator Complications Inappropriate defibrillation or cardioversion of a patient (e.g., with no malignant arrhythmia) may precipitate ventricular fibrillation, asystole, or other dangerous arrhythmias. Defibrillation without proper application of electrode pads or paddle electrolyte gel may be ineffective and cause burns, particularly when repeated shocks are necessary. Erythema or hyperemia of the skin under the paddles or MFE Pads often occurs; this effect is usually enhanced along the perimeter of the paddle or electrode. This reddening should substantially lessen within 72 hours. 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 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) Non-invasive Transcutaneous Pacing (NTP) is an established and proven technique. This therapy is easily and rapidly applied in both emergency and non-emergency situations when temporary cardiac stimulation is indicated. Intended Use - Pacemaker This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endlocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. 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, 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 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 drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implantation or the introduction of transvenous therapy. In such situations, 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. Pacemaker Complications Ventricular fibrillation will not respond to pacing and requires immediate defibrillation. The patient's dysrhythmia must therefore be determined immediately, so that appropriate therapy can be employed. If the patient is in ventricular fibrillation and defibrillation is successful, but cardiac standstill (asystole) ensues, the pacemaker should be used. Ventricular or supraventricular tachycardias may be interrupted with pacing but in an emergency or during circulatory collapse, synchronized cardioversion is faster and more certain. Electromechanical dissociation may occur following prolonged cardiac arrest or in other disease states with myocardial depression. Pacing may then produce ECG responses without effective mechanical contractions, and other treatment is required. Pacing may 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 may cause discomfort of varying intensity, which occasionally can be severe and preclude its continued use in conscious patients. Similarly, unavoidable skeletal muscle contraction may be troublesome in very sick patients and may limit continuous use to a few hours. Erythema or hyperemia of the skin under the MFE Pads often occurs; this effect is usually enhanced along the perimeter of the electrode. This reddening should substantially lessen within 7.2 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 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 must not be connected to internal pacemaker electrodes. Pediatric Pacing Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended. Monitor Intended-Use Multi-parameter Monitoring This product may be used for monitoring various patient vital signs, including: electrocardiogram (EGG), Pulse Oximetry (SP02), End Tidal GO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP). ECG monitoring is indicated by connecting the patient to the unit via the 3 or 5 lead patient cable, MFE Pads, or through the paddles. SP0 2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. EtCO 2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO 2) and respiration rate for adult, pediatric and neonatal patients. 12 Lead ECG Analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction. NIBP monitoring is indicated for the non-invasive measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

Source page: https://510kreport.com/device/K081081
Methodology: https://510kreport.com/methodology