# K042007: Zoll E Series Defibrillator

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corp
- Decided: Apr 7, 2005 after 255 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 17 ancestors in all.
64 later devices descend from it; 9 cite it directly.
1 of 82 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990762: Zoll M Series with Rectilinear BI-Phasic Option (M Series BI-Phasic), Zoll Medical Corp (1999) Summary page 2.
- K982992: Zoll M Series SPO2 Option, Zoll Medical Corp (1999) Summary page 2.
- K993036: Zoll M Series ETCO2 Option, Zoll Medical Corp (2000) Summary page 2.
- K991556: Zoll M Series 12SL Analysis Option, Zoll Medical Corp (1999) Summary page 2.
- K032363: Zoll M Series Nibp Option, Zoll Medical Corp (2003) Summary page 2.
- K033474: Zoll Aed Plus, Zoll Medical Corp (2004) Summary page 2.

## Most influential descendants
- K090989: Zoll R Series with Nibp and ETCO2 Options, Zoll R Series (2009), 27 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K060559: Zoll R Series Defibrillator (2006), 21 descendants of its own
- K171121: Masimo Root Monitoring System and Accessories (2017), 16 descendants of its own
- K110168: Zoll E Series with 2010 Aha Guidlines Software Update (2011), 15 descendants of its own

## Recalls of this device
- Apr 21, 2011 · Not classified · Z-2294-2011: Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy
- Mar 24, 2010 · Not classified · Z-1547-2010: Device issued Shock Advised message but failed to auto-charge the defibrillator.
- Jan 15, 2008 · Not classified · Z-1167-2008: Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisi

## 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. External Pacemaker (Pacer Version Only) Intended Use - Pacemaker This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial 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, 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 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 (ECG), Pulse Oximetry (SpO2), End Tidal CO2, 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. SpO2 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. EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) 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 measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

Source page: https://510kreport.com/device/K042007
Methodology: https://510kreport.com/methodology