← Back to catalogue

HeartSine Samaritan Pad 350P

FDA 510(k)

Class III (US FDA 510(k))

510(k) K123881

by Heartsine Technologies, Inc.

Identifiers

510(k) Number
K123881 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 350P is an Automated External Defibrillator (Non-Wearable), designed to deliver shock therapy for the treatment of sudden cardiac arrest. It provides semi-automatic defibrillation, requiring user confirmation before delivering a shock to restore normal heart rhythm in victims of ventricular fibrillation or pulseless ventricular tachycardia.

This device is supplied as a single-use, non-reusable unit and is intended for use in public access, workplace, and home settings. It features IP55-rated environmental protection against dust and water ingress, ensuring reliable operation in varied conditions. The HeartSine Samaritan Pad 350P has received FDA 510(k) clearance under the Traditional pathway and is classified as a Class III medical device under regulation number 870.5310.

Frequently asked questions

Is the HeartSine Samaritan Pad 350P designed for repeated use in clinical settings, or is it meant for single-use only?

The HeartSine Samaritan Pad 350P is explicitly designed as a single-use, non-reusable device. This is clearly stated in the description, ensuring it is intended for one-time use in public access, workplace, or home settings to maintain reliability and safety standards.

How does the HeartSine Samaritan Pad 350P handle environmental conditions, and where would it be suitable for deployment?

The device features IP55-rated environmental protection, meaning it is resistant to dust and low-pressure water jets. This makes it suitable for deployment in varied conditions, including public spaces, workplaces, and homes where exposure to moisture or dust may occur.

What type of regulatory pathway was followed for the FDA clearance of the HeartSine Samaritan Pad 350P, and what classification does it hold?

The HeartSine Samaritan Pad 350P received FDA 510(k) clearance under the Traditional pathway, and it is classified as a Class III medical device under regulation number 870.5310. This classification aligns with its critical role in treating sudden cardiac arrest.

Can this device be used in settings where reliability against water exposure is important, such as outdoor or high-moisture environments?

Yes, the HeartSine Samaritan Pad 350P is designed with IP55-rated environmental protection, which means it is resistant to dust and low-pressure water jets. This makes it suitable for use in outdoor or high-moisture environments, ensuring reliable operation in varied conditions.

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: HeartSine Connected samaritan PAD 350P, PDF USER MANUAL HeartSine samaritan PAD, PDF HeartSine® samaritan® PAD 350P/360P AEDs - Stryker, Heartsine Samaritan PAD 350P / 360P - American AED, HeartSine® Samaritan® PAD 350P AED - Cardiac Life Products Inc

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) K123881 24 fields · synced Sep 18, 2026