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HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE - M3840a

FDA 510(k)

Class III (US FDA 510(k))

510(k) K013425

by Philips Medical Systems

Identifiers

510(k) Number
K013425 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)
Models / Variants
M3860a FDA 510(k)
M3861a FDA 510(k)
M3840a FDA 510(k)
M3841a 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)

This device is an ECG cable designed for use with automated external defibrillators (non-wearable), specifically the Heartstream/Heartstart FR2 series. It facilitates the attachment of electrodes to a patient’s chest to enable real-time electrocardiogram (ECG) monitoring and analysis during defibrillation procedures, ensuring accurate rhythm assessment and shock delivery.

The ECG cable is supplied as a single-use, non-sterile component intended for use in out-of-hospital and pre-hospital cardiac arrest scenarios. It is compatible with the Heartstream/Heartstart FR2 defibrillator and must be used in accordance with the device’s instructions for use. The cable is classified as a Class III medical device under FDA regulations (21 CFR 870.5310) and holds a 510(k) clearance (K013425) for substantial equivalence to a predicate device.

Frequently asked questions

What is the primary purpose of the Heartstream/Heartstart FR2 AED ECG Cable, and how does it integrate with the defibrillator?

The Heartstream/Heartstart FR2 AED ECG Cable is designed to connect electrodes to a patient’s chest during defibrillation procedures, enabling real-time ECG monitoring and analysis. This allows the automated external defibrillator (AED) to assess the patient’s heart rhythm accurately and determine if a shock is needed, ensuring precise shock delivery when required.

Are these ECG cables reusable or single-use, and what does that mean for their use in emergency settings?

These ECG cables are explicitly labeled as single-use components, meaning they are intended for one-time use only. This design choice helps maintain hygiene and reliability in out-of-hospital or pre-hospital cardiac arrest scenarios, where sterility and consistency are critical to patient safety and effective treatment.

What models are available for the Heartstream/Heartstart FR2 AED ECG Cable, and are they interchangeable?

The available models are M3860A, M3861A, M3840A, and M3841A. While these models are designed for compatibility with the Heartstream/Heartstart FR2 defibrillator, their interchangeability should be verified against the specific AED model and electrode type being used, as slight variations in design may exist between models.

How should the ECG cables be stored, and what considerations should be made for their shelf life?

The cables are non-sterile and supplied as single-use items, so storage should follow standard medical device guidelines to protect them from physical damage, contamination, or environmental exposure. Since they are not sterilized, they should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer’s instructions for use should be consulted for any specific storage recommendations or expiration details.

What regulatory pathway was followed for the FDA clearance of this ECG cable, and what does that mean for its use?

The Heartstream/Heartstart FR2 AED ECG Cable received FDA clearance through a 510(k) submission, classified as substantially equivalent to a predicate device under 21 CFR 870.5310 (Automated External Defibrillators). This means the device was evaluated by the FDA’s Cardiovascular (CV) Advisory Committee and determined to have the same intended use, technological characteristics, and performance as a legally marketed predicate, ensuring it meets safety and effectiveness standards for use in out-of-hospital cardiac arrest scenarios.

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) K013425 24 fields · synced Sep 18, 2026