Reduced Energy Pediatric Electrode Pads for the Samaritan AED and Pad, Models SDE 251, SPP 351
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K052465 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 Reduced Energy Pediatric Electrode Pads for the Samaritan AED and Pad are single-use adhesive electrodes designed for pediatric defibrillation. These pads deliver reduced energy shocks to minimize trauma in children during cardiac arrest, aligning with Automated External Defibrillators (Non-Wearable) as classified by regulatory authorities. They are specifically engineered to interface with the Samaritan AED and Pad systems, ensuring compatibility for pediatric resuscitation efforts.
These electrode pads are supplied sterile and intended for single-use only, adhering to FDA 510(k) clearance under the Cardiovascular advisory committee. They are non-reusable and must be discarded after one use to maintain sterility and safety. The pads are classified as Class III medical devices under FDA regulation 870.5310, with no MRI safety considerations specified. Storage should follow manufacturer guidelines to preserve sterility and functionality prior to use.
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 | K052465 | Class III | Active |
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Manufacturer
- Manufacturer
- Heartsine Technologies, Inc.
Sources (1)
- FDA 510(k) K052465 24 fields · synced Sep 18, 2026