← Back to catalogue

Heartsine Samaritan Pad

FDA 510(k)

Class III (US FDA 510(k))

510(k) K041067

by Heartsine Technologies, Inc.

Identifiers

510(k) Number
K041067 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 Heartsine Samaritan Pad is an Automated External Defibrillator (Non-Wearable), designed to deliver an electric shock to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It provides voice prompts and visual guidance to assist bystanders in performing cardiopulmonary resuscitation (CPR) and defibrillation, ensuring timely intervention during emergencies.

This device is supplied as a single-use, non-reusable unit intended for emergency use in pre-hospital and public-access settings. It is classified as a Class III medical device under FDA regulations (870.5310) and requires FDA clearance (510K). The Samaritan Pad is MRI-safe and includes adhesive pads for electrode placement. Storage conditions are not specified but must adhere to manufacturer instructions to maintain functionality.

Frequently asked questions

Is the Heartsine Samaritan Pad designed for repeated use in clinical settings, or is it intended as a single-use device for emergencies?

The Heartsine Samaritan Pad is explicitly designed as a single-use, non-reusable device. It is intended for emergency use in pre-hospital and public-access settings, such as cardiac arrest scenarios where immediate intervention is critical. This design ensures reliability and safety during high-stakes situations, as reuse could compromise performance or sterility.

Does the device include adhesive pads for electrode placement, and if so, how are they integrated into the design?

Yes, the Heartsine Samaritan Pad includes adhesive pads for electrode placement as part of its design. These pads are used to attach the defibrillator electrodes to the patient’s chest, enabling the device to deliver shocks and monitor heart rhythm during resuscitation efforts. The pads are part of the single-use unit, ensuring proper functionality and hygiene for each emergency.

What storage conditions should be followed to maintain the device’s functionality, and are there any special considerations for handling?

While the device data does not specify exact storage conditions, it emphasizes that manufacturer instructions must be adhered to to preserve functionality. This likely includes protecting the device from extreme temperatures, moisture, or physical damage. Since it is a single-use emergency device, it should also be stored in a secure, accessible location where it can be quickly retrieved during a cardiac arrest event.

How does the Heartsine Samaritan Pad assist bystanders in performing CPR and defibrillation, and what features does it provide?

The device provides voice prompts and visual guidance to assist bystanders in performing CPR and defibrillation. This includes step-by-step instructions for chest compressions, electrode placement, and when to deliver a shock, ensuring timely and correct intervention during sudden cardiac arrest. These features are critical for non-medical responders in emergency situations.

Is the Heartsine Samaritan Pad compatible with MRI environments, and what does that mean for its use in healthcare facilities?

Yes, the device is MRI-safe, meaning it can be used in or near MRI environments without interfering with MRI equipment or posing risks to patients undergoing imaging. This makes it suitable for healthcare facilities where cardiac arrest may occur near MRI machines, ensuring the device remains functional and safe in such settings.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Heartsine Technologies, Inc.

Sources (1)

  • FDA 510(k) K041067 24 fields · synced Sep 18, 2026