# K990762: Zoll M Series with Rectilinear BI-Phasic Option (M Series BI-Phasic)

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corp
- Decided: Sep 3, 1999 after 179 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
No predicates in its family tree.
66 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K042007: Zoll E Series Defibrillator (2005), 64 descendants of its own
- 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

## Indications for use
The ZOLL M Series Bi-Phasic Defibrillator is to be used only by qualified medical personnel for converting ventricular fibrillation (VF), a cardiac rhythm incompatible with life, and/or Ventricular Tachycardias (VT) to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Atrial Fibrillation (AF) at lower energy and currents than monophasic defibrillators. A qualified physician must decide when synchronized cardioversion is appropriate. In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Ventricular Tachycardias (VT). A qualified physician must decide when synchronized cardioversion is appropriate. The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, and proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices. The M Series Biphasic Option incorporates some user selectable energy settings, which are lower than those used during those clinical trials. There are currently no clinical studies related to the use of the Rectilinear Biphasic Waveform (RBW) in pediatric applications. o he-M-Sades-Riphasic-optiomisestindicatedfor direct defibrillation of the heart during open chest surgica Corocedures. The AED or advisory function should only be used to confirm the presence of ventricular fibriltation in patients meeting the following clinical criteria: ¢ the patient should be unconscious and unresponsive o the patient should be apneic (not breathing) e the patient should be pulseless Warning Do not use the unit's AED function on patients under 8 years of age. (Per AHA Guidelines for Adult Cardiopulmonary Resuscitation and AED, 3-5, 1998).

Source page: https://510kreport.com/device/K990762
Methodology: https://510kreport.com/methodology