# K080903: Zoll E Series with Intibation Assist Option

- Pathway: 510(k) (Special)
- Applicant: ZOLL Medical Corporation
- Decided: Dec 4, 2008 after 247 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.
3 later devices descend from it; 2 cite it directly.
1 of 22 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 1.

## Most influential descendants
- K130153: Hearstart MRX with Airway Confimration Assist (2013), 2 descendants of its own
- K133659: Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring (2015), 1 descendant of its own
- K200849: Tempus LS - Manual (2020), 0 descendants of its own

## Indications for use
The ZOLL E Series with Intubation Assist Option is intended to provide the user with a simple way of counting breaths as detected by a capnometer once the Endotracheal Tube (ET) has been placed and the rescuer is delivering the first initial ventilations. Ventilations can be counted based on EtCO2 and/or tranthoracic impedance.

Source page: https://510kreport.com/device/K080903
Methodology: https://510kreport.com/methodology