# K133659: Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jan 23, 2015 after 422 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: 12 generations back to K962603 (1997). 57 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110825: Philips Heartstart XL+, Philips Heartstart External Paddles, Philips Multifunction Electrodes, Philips Medical Systems (2012) Summary page 4.
- K130153: Hearstart MRX with Airway Confimration Assist, Philips Medical Systems (2013) Summary page 4.
- K080903: Zoll E Series with Intibation Assist Option, ZOLL Medical Corporation (2008) Summary page 4.
- K090989: Zoll R Series with Nibp and ETCO2 Options, Zoll R Series, Zoll Medical Corp (2009) Summary page 4.

## Most influential descendants
- K200849: Tempus LS - Manual (2020), 0 descendants of its own

## Indications for use
The HeartStart XL+ is a defibrillator/monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician. AED Therapy: AED mode is used in the presence of suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless. Manual Defribillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation (cardioversion) is indicated for termination of certain atrial and ventricular arrhythmias. Non-Invasive External Pacing: The pacing option is indicated for treating patients with symptomatic bradycardia. Pulse Oximetry: The SpO2 option is indicated for use when it is beneficial to assess the patient’s oxygen saturation level. Non-Invasive Blood Pressure Monitoring: The NBP option is indicated for non-invasive measurement of a patient’s arterial blood pressure. End-Tidal CO2: The EtCO2 option is intended for noninvasive monitoring of a patient’s exhaled carbon dioxide and to provide a respiration rate. ECG Monitoring: ECG monitoring is indicated to be used for monitoring, alarming and recording of the patient’s heart rate and morphology.

Source page: https://510kreport.com/device/K133659
Methodology: https://510kreport.com/methodology