Samaritan Pad Pak Defibrillation Electrode, Model SPP-301
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K042088 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 Pad Pak Defibrillation Electrode, Model SPP-301, is a single-use, non-wearable automated external defibrillator electrode designed for ECG monitoring and defibrillation. These self-adhesive hydrogel pads deliver defibrillation shocks to restore normal heart rhythm during cardiac arrest, adhering directly to the patient’s chest for effective electrical conduction.
Supplied as a non-sterile, pre-packaged unit, the SPP-301 is intended for emergency use in out-of-hospital settings, including public spaces, workplaces, and first-responder environments. Each electrode is paired with a battery module, ensuring a single expiration date for simplified maintenance. The device complies with FDA 510(k) clearance under the classification of Automated External Defibrillators (Non-Wearable) and adheres to regulation number 870.5310.
Frequently asked questions
What is the primary purpose of the Samaritan Pad Pak Defibrillation Electrode, Model SPP-301, and where is it typically used?
The Samaritan Pad Pak Defibrillation Electrode, Model SPP-301, is designed for ECG monitoring and delivering defibrillation shocks to restore a normal heart rhythm during cardiac arrest. It is intended for use in out-of-hospital settings, such as public spaces, workplaces, and environments where first responders may be deployed, ensuring immediate access to defibrillation capabilities when needed.
Is the SPP-301 electrode reusable, and if not, what does this mean for maintenance and storage?
No, the SPP-301 is explicitly labeled as a single-use device. This means each electrode and its paired battery module are intended for one-time use only, simplifying maintenance by eliminating the need for cleaning or reprocessing. Since they share an expiration date, users must replace the entire unit (pads + battery) once expired, ensuring consistent performance and safety.
Are the SPP-301 electrodes sterile, and what does this imply for their handling in emergency scenarios?
The SPP-301 electrodes are non-sterile, meaning they are not intended for use in sterile procedures or invasive applications. In emergency cardiac arrest scenarios, this is acceptable because the primary goal is rapid defibrillation, and the pads are designed for direct chest adhesion without requiring sterile conditions. Proper hand hygiene and adherence to infection control guidelines remain critical for responders.
How is the SPP-301 packaged, and what should buyers consider when storing these units?
The SPP-301 is supplied as a pre-packaged unit, combining the defibrillation electrodes with a battery module. Buyers should store these units in a cool, dry place away from direct sunlight and extreme temperatures to preserve functionality and ensure the shared expiration date remains valid. Since it’s single-use, stock should account for regular turnover to avoid expiration waste.
What regulatory pathway does the SPP-301 follow, and what does this mean for purchasers or clinicians?
The SPP-301 is FDA 510(k) cleared under the classification of Automated External Defibrillators (Non-Wearable), with a decision described as *Substantially Equivalent* to a predicate device. This clearance confirms the device meets U.S. safety and performance standards for its intended use in emergency cardiac arrest scenarios. Purchasers or clinicians can rely on this regulatory status as evidence of compliance with FDA requirements for non-wearable defibrillator electrodes.
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: Samaritan Pad Pak Defibrillation Electrode, Model Spp-301, HeartSine™ samaritan® PAD-PAK™ - AED Superstore - PAD-PAK-01, fda.innolitics.com, Heartsine Samaritan PAD PAK | battery and electrodes ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042088 | Class III | Active |
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Manufacturer
- Manufacturer
- Heartsine Technologies, Inc.
Sources (1)
- FDA 510(k) K042088 24 fields · synced Sep 18, 2026