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Hearstart Mrx With Airway Confimration Assist

FDA 510(k)

Class III (US FDA 510(k))

510(k) K130153

by Philips Medical Systems

Identifiers

510(k) Number
K130153 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 MRX with Airway Confirmation Assist is an Automated External Defibrillator (Non-Wearable), designed to deliver defibrillation therapy and advanced patient monitoring. It incorporates airway confirmation assist technology to enhance resuscitation efforts by providing real-time feedback during airway management procedures, supporting qualified medical personnel in emergency cardiac care scenarios.

This device is intended for use in hospital and pre-hospital settings by trained personnel, including those qualified in basic life support, advanced life support, advanced cardiac life support, or defibrillation. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K130153) and falls under Class III medical device classification (870.5310). The device is not single-use and requires proper storage and maintenance as per manufacturer guidelines.

Frequently asked questions

Is the HeartStart MRX with Airway Confirmation Assist designed for single-use or reusable in clinical settings?

The HeartStart MRX with Airway Confirmation Assist is explicitly labeled as a reusable medical device. Since it is not intended for single-use, it requires proper maintenance, cleaning, and storage as outlined by Philips Medical Systems to ensure reliable performance and safety in both hospital and pre-hospital emergency cardiac care scenarios.

What types of healthcare professionals are authorized to use this defibrillator, and where can it be deployed?

This device is intended for use by trained personnel, including those qualified in basic life support (BLS), advanced life support (ALS), advanced cardiac life support (ACLS), or defibrillation. It is designed for deployment in hospital and pre-hospital settings, such as ambulances, emergency rooms, and cardiac care units, where immediate cardiac resuscitation may be required.

Does the HeartStart MRX with Airway Confirmation Assist provide any additional features beyond standard defibrillation?

Yes, this device incorporates airway confirmation assist technology, which provides real-time feedback during airway management procedures. This feature helps qualified medical personnel enhance resuscitation efforts by verifying proper airway placement, improving the accuracy and efficiency of emergency cardiac care.

What regulatory pathway was followed for FDA clearance of this device, and how is it classified?

The HeartStart MRX with Airway Confirmation Assist received FDA 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). It is classified as a Class III medical device under the FDA’s product code 870.5310, indicating it is intended for high-risk use in defibrillation and advanced patient 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. Sources consulted: Philips - HeartStart MRx Monitor/Defibrillator for emergency care, Hearstart Mrx With Airway Confimration Assist, HeartStart MRx Defibrillator Monitor - Philips - Recertified

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) K130153 24 fields · synced Sep 18, 2026