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Heartstart Xl+defibrillator/Monitor With End-Tidal Carbon Dioxide Monitoring

FDA 510(k)

Class III (US FDA 510(k))

510(k) K133659

by Philips Medical Systems

Identifiers

510(k) Number
K133659 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.5310 FDA 510(k)
Regulation Number
870.5310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The HeartStart XL+ Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring is an automated external defibrillator (non-wearable) designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It combines defibrillation capabilities with real-time monitoring of vital signs, including electrocardiogram (ECG) and end-tidal carbon dioxide (EtCO₂) levels, to assess respiratory function and cardiac activity during resuscitation efforts.

This device is intended for use in pre-hospital, emergency department, and clinical settings by trained healthcare providers. Supplied as a reusable medical device, it requires proper calibration and maintenance in accordance with manufacturer guidelines. The HeartStart XL+ is classified as a Class III device under FDA regulations (870.5310) and holds a 510(k) clearance (K133659) for substantial equivalence. Storage and handling must comply with regulatory standards to ensure device functionality and patient safety.

Frequently asked questions

Is this defibrillator suitable for use in both emergency and clinical settings, and what makes it different from standard models?

Yes, the HeartStart XL+ Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring is designed for use in pre-hospital, emergency department, and clinical settings by trained healthcare providers. What distinguishes it is its integrated end-tidal carbon dioxide (EtCO₂) monitoring capability, allowing real-time assessment of respiratory function and cardiac activity during resuscitation efforts, which standard defibrillators typically lack.

How is this device supplied, and what maintenance requirements should I be aware of?

The HeartStart XL+ is supplied as a reusable medical device, meaning it is intended for repeated use after proper cleaning, calibration, and maintenance. Since it is reusable, it requires adherence to manufacturer guidelines for servicing to ensure accurate defibrillation, monitoring, and EtCO₂ readings. Regular maintenance is critical to preserve functionality and patient safety.

Does this device come in multiple sizes or models, and if so, how do I determine which one is right for my facility?

The provided data does not specify multiple sizes or models for the HeartStart XL+ Defibrillator/Monitor with EtCO₂ Monitoring. However, it is classified under the product code MKJ (Automated External Defibrillators) and is intended for general use across pre-hospital, emergency, and clinical settings. Facilities should confirm compatibility with their specific workflows and consult Philips Medical Systems for any customization or configuration options.

What regulatory pathway was followed for this device’s clearance, and how does that affect its use?

The HeartStart XL+ received FDA 510(k) clearance (K133659) under the traditional review pathway, with a decision of substantial equivalence (SESE) in the Cardiovascular (CV) advisory committee. This means it was deemed comparable to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for automated external defibrillators. The clearance does not restrict its use but confirms it adheres to regulatory requirements for Class III devices.

Can you clarify what the end-tidal carbon dioxide (EtCO₂) monitoring feature adds to resuscitation efforts?

The EtCO₂ monitoring feature provides real-time feedback on a patient’s respiratory function during resuscitation by measuring exhaled carbon dioxide levels. This helps healthcare providers assess whether chest compressions are effective, confirm return of spontaneous circulation (ROSC), and monitor ventilation status—critical information not available with standard defibrillators. It enhances decision-making during cardiac arrest scenarios by offering additional physiological data alongside ECG monitoring.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems

Sources (1)

  • FDA 510(k) K133659 24 fields · synced Oct 6, 2026