Identifiers
- 510(k) Number
- K023854 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 Samaritan AED Model SAM-01 is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It provides voice prompts and visual guidance to assist untrained responders in performing cardiopulmonary resuscitation (CPR) and defibrillation.
This device is intended for single-use and is supplied as a portable, non-rechargeable unit. It is classified as a Class III medical device under FDA regulations (870.5310) and has received FDA 510(k) clearance through a traditional review process. The device is not MRI-safe and must be stored in its original packaging until use, adhering to manufacturer instructions for optimal performance and sterility.
Frequently asked questions
What is the primary purpose of the Samaritan AED Model SAM-01, and how does it assist untrained responders during emergencies?
The Samaritan AED Model SAM-01 is designed to restore normal heart rhythm in patients experiencing sudden cardiac arrest by delivering electrical shocks. It guides untrained responders through voice prompts and visual cues to perform CPR and defibrillation, ensuring proper use even without medical training.
Is the Samaritan AED Model SAM-01 intended for reuse, or is it meant to be used only once?
The device is explicitly designed for single-use only, meaning it should not be reused after a single deployment. This ensures optimal performance and sterility, as it must remain in its original packaging until use.
How should the Samaritan AED Model SAM-01 be stored to maintain its functionality and sterility?
The device must be stored in its original packaging until use, following the manufacturer’s instructions. This preserves sterility and ensures the unit remains ready for deployment when needed.
What regulatory pathway was followed for FDA clearance of the Samaritan AED Model SAM-01?
The device received FDA 510(k) clearance through a traditional review process, classified as a Class III medical device under regulation number 870.5310. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device.
Can the Samaritan AED Model SAM-01 be used in an MRI environment, or does it pose any safety concerns?
The device is not MRI-safe, meaning it should not be used in or near an MRI environment. This is explicitly noted in the manufacturer’s instructions to prevent interference or safety risks.
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 | K023854 | Class III | Active |
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Manufacturer
- Manufacturer
- Heartsine Technologies, Inc.
Sources (1)
- FDA 510(k) K023854 24 fields · synced Sep 18, 2026