# K972241: Zoll Reviver

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corp
- Decided: Mar 16, 1998 after 273 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 23, 2003 · Not classified · Z-1000-03: Defibrillator may fail to charge or hold its charge above energies of 75 joules

## Indications for use
Defibrillator Function Indications for Use — Manual Operation Use of the ZOLL REVIVER 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. The ZOLL REVIVER contains a standard DC defibrillator capable of delivering up to 360 joules of energy. In manual mode, it may also be used for synchronized cardioversion by using the R-wave of the patient’s ECG as a timing reference. This product is to be used only by qualified medical personnel for the purposes of converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Indications for Use — Advisory Function The advisory function should only be used to confirm ventricular fibrillation and ventricular tachycardia (greater than 150 beats per minute) in patients meeting the following clinical criteria: *- Unconsciousness *+ Absence of breathing < Absence of pulse. Indications for Use — Semiautomatic Operation (if equipped) The ZOLL REVIVER is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the operator of the device controls the delivery of the shock to the patient. It is 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 in a medically-approved patient care protocol. The ZOLL REVIVER must be prescribed for use by a physician or medical advisor of an emergency response team. Use of the ZOLL REVIVER 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. Pacemaker Function (if equipped) Indications for Use — Pacemaker This product may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The purposes of pacing include: 1 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. 2 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 imptants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing may provide an alternative to transvenous therapy which avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing. 3 Suppression of tachycardia: An increase in heart rate from external pacing often suppresses ventricular ectopic activity and may prevent tachycardia.

Source page: https://510kreport.com/device/K972241
Methodology: https://510kreport.com/methodology