Identifiers
- 510(k) Number
- K954609 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 911 is an Automated External Defibrillator (Non-Wearable), designed to deliver electric shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It provides voice prompts and visual guidance to assist lay responders and healthcare professionals in performing cardiopulmonary resuscitation (CPR) and defibrillation.
Supplied as a reusable device, the Heartstart 911 is intended for use in pre-hospital, emergency, and clinical settings. It is classified as a Class III medical device under FDA regulations (870.5310) and holds a 510(k) clearance (K954609) with a substantially equivalent determination. The device is not indicated for MRI use and requires proper storage and maintenance as outlined in manufacturer instructions.
Frequently asked questions
What types of settings is the Heartstart 911 intended for use in, and how does its reusable design impact its deployment?
The Heartstart 911 is designed for use in pre-hospital, emergency, and clinical settings where sudden cardiac arrest may occur. As a reusable device, it is built for repeated use across multiple patients, making it ideal for environments like ambulances, emergency rooms, and public spaces where reliability and durability are critical. The reusable nature also allows for regular maintenance and updates to ensure consistent performance over time.
Is the Heartstart 911 compatible with magnetic resonance imaging (MRI) environments, and why might this matter for some buyers?
No, the Heartstart 911 is explicitly not indicated for MRI use. This matters for buyers in hospitals or clinics with MRI facilities, as the device cannot be used in or near MRI environments without risking interference or damage to either the device or the MRI system. Always follow manufacturer guidelines for storage and use away from MRI zones.
How does the Heartstart 911 assist users during a cardiac emergency, and who is it designed to support?
The Heartstart 911 provides voice prompts and visual guidance to guide both lay responders (e.g., untrained bystanders) and healthcare professionals through cardiopulmonary resuscitation (CPR) and defibrillation. Its automated external defibrillator (non-wearable) function delivers electric shocks to restore a normal heart rhythm, making it accessible for users with varying levels of medical training in emergency situations.
What regulatory pathway was followed for the Heartstart 911, and what does this mean for its use in the U.S.?
The Heartstart 911 received FDA 510(k) clearance (K954609) under a substantially equivalent determination, classified as a Class III medical device (FDA code 870.5310). This means it meets FDA standards for safety and effectiveness as a non-wearable automated external defibrillator, allowing legal use in pre-hospital, emergency, and clinical settings across the U.S. under its approved indications.
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 | K954609 | Class III | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical Corp.
Sources (1)
- FDA 510(k) K954609 24 fields · synced Sep 18, 2026