Identifiers
- 510(k) Number
- K040404 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 Model M3535A is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. This device provides voice prompts and visual guidance to assist lay responders in performing cardiopulmonary resuscitation (CPR) and defibrillation, ensuring timely intervention during cardiac emergencies.
Supplied as a reusable medical device, the HeartStart MRX Model M3535A is intended for use in pre-hospital, emergency room, and clinical settings. It operates within Class III regulatory classification under FDA regulations (870.5310) and has received a Traditional 510(k) clearance through the Cardiovascular Advisory Committee. The device requires proper maintenance and calibration as specified by the manufacturer to ensure reliable performance.
Frequently asked questions
What types of settings is the HeartStart MRX Model M3535A intended for use in and why?
The HeartStart MRX Model M3535A is designed for use in pre-hospital environments, emergency rooms, and clinical settings. This is because it is an Automated External Defibrillator (Non-Wearable) that provides voice prompts and visual guidance to assist responders in performing CPR and defibrillation, ensuring timely intervention during cardiac emergencies across these critical care environments.
Is the HeartStart MRX Model M3535A a single-use or reusable device, and what does this mean for maintenance?
The HeartStart MRX Model M3535A is a reusable medical device. This means it is built to be used repeatedly across multiple patients, but it requires proper maintenance and calibration as specified by Philips Medical Systems to ensure reliable performance and safety over time.
How is the regulatory pathway for the HeartStart MRX Model M3535A structured, and what does this imply for its use?
The HeartStart MRX Model M3535A received a Traditional 510(k) clearance through the Cardiovascular Advisory Committee, indicating it was determined to be substantially equivalent to a legally marketed predicate device. This regulatory route ensures the device meets FDA standards for safety and effectiveness as a Class III device under classification 870.5310, suitable for use in emergency cardiac care settings.
What guidance does the device provide to users during an emergency, and who is it intended for?
The HeartStart MRX Model M3535A provides voice prompts and visual guidance to assist lay responders—such as first responders, bystanders, or untrained individuals—in performing cardiopulmonary resuscitation (CPR) and defibrillation. This ensures even non-medical personnel can effectively respond to sudden cardiac arrest situations.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040404 | Class III | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K040404 24 fields · synced Sep 18, 2026