# K130153: Hearstart MRX with Airway Confimration Assist

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Mar 12, 2013 after 49 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: 11 generations back to K962603 (1997). 54 ancestors in all.
2 later devices descend from it; 1 cites it directly.
5 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061707: Heartstart MRX, Invasive Pressure & Temperature Options, Philips Medical Systems (2006) Summary page 1.
- K082268: CAPNOSTREAM20 with Integrated Pulmonary Index, Oridion Capnography, Inc. (2009) Summary page 1.
- K080903: Zoll E Series with Intibation Assist Option, ZOLL Medical Corporation (2008) Summary page 1.

## Most influential descendants
- 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 HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and puls~less. Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for the termination of certain atrial and ventricular arrhythmias. Noninvasive External Pacing Therapy: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early. Pulse Oximetry: The Sp0 2 option is intended for use when it is beneficial to assess the patient's oxygen saturation level. Noninvasive Blood Pressure Monitoring: The NEP option is intended for noninvasive measurement of a patient's arterial blood pressure. End-Tidal C02: The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate. 12-Lead EGG: The 12-Lead ECU function is to provide a conventional diagnostic 12-Lead-EG report, which may include measurement and interpretative statements. O-CPR: The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AT-A/ERG guidelines for chest compression rate depth, and duty cycle and ventilation rate, volume and flow rate (inflation time). Invasive Pressures: The Invasive Pressures option is indicated for measuring arterial, venous, intracranial, and other physiological pressures on patients. Temperature: The Temperature option is indicated for measure temperature in patients.

Source page: https://510kreport.com/device/K130153
Methodology: https://510kreport.com/methodology