# K081574: Zoll R Series

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Sep 18, 2008 after 105 days
- Product code: LDD (Dc-Defibrillator, Low-Energy, (Including Paddles))
- Device class: 2
- Regulation: 21 CFR 870.5300
- 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 2.

## 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
Defibrillator Function 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 Operatio (AED) The 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 involing 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

Source page: https://510kreport.com/device/K081574
Methodology: https://510kreport.com/methodology