# K091265: Zoll E Series with Cprreadycharge

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corporation, World Wide Headquarters
- Decided: Dec 23, 2009 after 237 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 defilbrillator capableof delivering up to 200 joules of energy. It may be used insynchronized mode to perform synchronized cardioversion by using the R-wave of the patient's EGG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for dlefibrillation. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team. Intended Use - Manual Operation Use of the E Series units inthe Manual mode for defilbrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: • Unconsciousness • Absence of breathing, and * 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 E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the Rwave of the patient's EGG as a timing reference. A qualified physician must decide when synchronized cardioversion is 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 (previously listed). Intended Use -- CPRReadyCharge Mode Use of the E Series unit in GPRReadyCharge Mode is designed for use by qualified medical personnel who have been trained in AGLS (Advanced Cardiac Life Support). The purpose of the CPRReadyCharge algorithm is to anticipate the need to deliver a therapy shock. CPRReady~harge Mode uses an advisory algorithm that is designed to perform in the presence of CPR artifact. However, the accuracy of the CPRReady~harge algorithm inthe presence of CPR artifact is lower than the accuracy observed in the Advisory or Semiautomatic (AED) algorithm used with artifact-free EGG. The advisory result should always be confirmed through visual inspection of the EGG rhythm by the operator before the delivery of any therapy. See Table A-A in Appendix A for a summary ofthe performance.E Series products with CPRReady~harge Mode are specifically designed for use in early defilbrillation programs where the delivery of a dlefibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically approved patient care protocol. Use of the E Series units inCPRReady~harge Mode for dlefibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation. E Series units in CPRReady~harge Mode, when used inconjunction with CPR-D padz, prompt the emergency care personnel to perform CPR, and perform rhythm analysis during GPR compressions. If an underlying shockable rhythm is detected during CPR, the E Series unit in CPRReady~harge Mode prepares the dlefibrillator to deliver a shock at the end of the CPR interval. Intended Use - Semiautomatic Operation (AED) The E Series AED unit is 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 device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation. Specifications for the EGG rhythm analysis function are provided at the end of this section. Intended Use - CPR 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 CPR monitoring function is not intended for use on patients under 8 years of age. Intended Use - Pacemaker This product may be used for temporary external cardiac pacing inconscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacinrg include: Resuscitation from standstill or bradycardia ofany 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 inpatients 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 attivity and may prevent tachycardia.

Source page: https://510kreport.com/device/K091265
Methodology: https://510kreport.com/methodology