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HeartStart 3000

FDA 510(k)

Class III (US FDA 510(k))

510(k) K896919

by Laerdal Medical Corp.

Identifiers

510(k) Number
K896919 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 3000 is an automated external defibrillator (non-wearable) designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It features a semi-automatic operation mode, an LCD monitor for ECG visualization, and integrated voice prompts to guide rescuers through resuscitation steps.

This device is battery-powered, portable, and intended for use in pre-hospital and emergency settings. Supplied as a reusable medical device, it requires proper training for operation and adherence to regulatory standards, including FDA 510(k) clearance under classification III. It is not MRI-compatible and must be stored according to manufacturer guidelines to maintain functionality and sterility.

Frequently asked questions

What is the primary purpose of the HeartStart 3000 in emergency situations and how does it guide rescuers during use?

The HeartStart 3000 is an automated external defibrillator (non-wearable) designed to restore normal heart rhythm in patients experiencing sudden cardiac arrest by delivering electrical shocks. It operates in semi-automatic mode, where rescuers apply the pads and press a shock button after the device analyzes the heart rhythm. The device includes an LCD monitor to display ECG readings and integrated voice prompts to guide rescuers step-by-step through the resuscitation process, ensuring proper use even in high-stress situations.

Is the HeartStart 3000 intended for single-use or reusable applications, and what maintenance considerations should be taken into account?

The HeartStart 3000 is supplied as a reusable medical device, meaning it is designed for repeated use after proper cleaning, maintenance, and calibration. Since it is not single-use, it requires adherence to manufacturer guidelines for storage, cleaning, and servicing to maintain functionality, sterility, and reliability. Regular training for operators is also essential to ensure safe and effective use over multiple deployments.

What regulatory pathway was followed for the HeartStart 3000’s FDA clearance, and what does this mean for its use in clinical settings?

The HeartStart 3000 received FDA clearance through a 510(k) submission, classified under classification III with a decision described as 'Substantially Equivalent' to a predicate device. This means the FDA determined it meets the same performance standards as an existing, legally marketed device. Clinically, this clearance indicates the device has undergone rigorous review for safety and effectiveness, allowing it to be used in pre-hospital and emergency settings as intended, provided operators follow FDA and manufacturer guidelines.

Can the HeartStart 3000 be used in environments with MRI equipment, and what storage guidelines should be followed to preserve its functionality?

No, the HeartStart 3000 is explicitly stated as not MRI-compatible, meaning it should never be used or stored near MRI machines, as electromagnetic interference could compromise its performance or safety. To maintain functionality and sterility, the device must be stored according to the manufacturer’s guidelines, which likely include protecting it from extreme temperatures, moisture, and physical damage—details that should be referenced in the device’s user manual or technical specifications.

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: Laerdal - HeartStart 3000QR Community, Manuals and Specifications ..., Parts for Heartstart® 3000 and Heartstart® 3000QR - laerdal.com, Parts for Heartstart® 3000 and Heartstart® 3000QR - laerdal.com, Laerdal HeartStart 3000 QR Monitor Defibrillator

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Laerdal Medical Corp.

Sources (1)

  • FDA 510(k) K896919 24 fields · synced Sep 18, 2026