Pro-Neo Neonatal ECG Electrode, Models SG15 and SR20
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K053011 FDA 510(k)
- FDA Product Code
- DRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2360 FDA 510(k)
- Regulation Number
- 870.2360 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pro-Neo Neonatal ECG Electrode is a neonatal electrocardiogram (ECG) electrode designed for monitoring the electrical activity of a newborn’s heart. These self-adhesive electrodes are specifically engineered to provide accurate and reliable ECG readings in neonatal patients, ensuring precise cardiac assessment during clinical evaluations.
The Pro-Neo Neonatal ECG Electrode is supplied as a single-use, sterile device for temporary attachment to a neonate’s skin. Models SG15 and SR20 are intended for use in neonatal intensive care units (NICUs) and pediatric cardiac monitoring settings. Compliance with FDA 510(k) clearance and MDR authorisations ensures adherence to regulatory standards for medical device safety and performance.
Frequently asked questions
Are the Pro-Neo Neonatal ECG Electrodes designed for reuse or are they single-use devices?
The Pro-Neo Neonatal ECG Electrodes are explicitly designed for single-use only. This is standard practice for neonatal ECG electrodes to ensure sterility, hygiene, and reliability during monitoring, as reusable electrodes could introduce contamination risks in sensitive neonatal environments.
What are the key differences between the SG15 and SR20 models of the Pro-Neo Neonatal ECG Electrode?
The SG15 and SR20 models are both neonatal ECG electrodes, but the manufacturer does not specify distinct clinical differences in the provided data. The models may vary in size, adhesive properties, or electrode configuration (e.g., single-gel vs. snap-resistant), which could influence ease of application or patient comfort. For precise differences, refer to the manufacturer’s technical documentation or consult Bio Protech Inc.
How should the Pro-Neo Neonatal ECG Electrodes be stored to maintain their sterility and performance?
Since these electrodes are sterile single-use devices, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is designed to preserve sterility, so avoid exposing the electrodes to moisture, chemicals, or physical damage before use.
What regulatory pathways have the Pro-Neo Neonatal ECG Electrodes undergone, and what does that mean for safety?
The Pro-Neo Neonatal ECG Electrodes have undergone FDA 510(k) clearance (traditional pathway, substantially equivalent determination) and MDR (Medical Device Regulation) authorization. This means the device has been evaluated by regulatory authorities to meet safety and performance standards for ECG monitoring in neonatal patients, ensuring compliance with both U.S. and EU medical device regulations.
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 (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K053011 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio Protech Inc.
- FDA Applicant
- Bio Protech, Inc.
Sources (2)
- FDA 510(k) K053011 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026