Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-…
FDA 510(k)Class II (US FDA 510(k))
by Covidien llc
Identifiers
- 510(k) Number
- K212555 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nellcor OxySoft Neonatal-Adult SpO₂ Sensor is a pulse oximetry sensor designed for non-invasive, continuous or intermittent monitoring of arterial oxygen saturation (SpO₂) in both neonatal and adult patients. It operates by transmitting light through tissue to measure oxygen levels in hemoglobin, providing real-time data on a patient’s oxygenation status. The device is categorized as a pulse oximeter sensor, adhering to standards for non-invasive monitoring of blood oxygenation. Its design prioritizes accuracy and reliability in diverse clinical settings, including low-perfusion and thick-tissue environments.
The OxySoftN sensor is supplied as a single-use, disposable device intended for use with compatible pulse oximeters in hospital, neonatal intensive care, and adult critical care environments. It is not intended for MRI use and must be handled according to manufacturer guidelines to ensure proper function and patient safety. The sensor is regulated under FDA 510(k) clearance (K212555) and is classified under product code DQA. Storage should follow the manufacturer’s instructions to maintain sensor integrity and performance.
Frequently asked questions
What clinical settings is the Nellcor OxySoft Neonatal-Adult SpO₂ Sensor intended for use in, and how does it differ from standard pulse oximetry sensors?
The Nellcor OxySoft Neonatal-Adult SpO₂ Sensor is specifically designed for use in hospital environments, including neonatal intensive care units (NICU) and adult critical care settings. Unlike standard pulse oximetry sensors, it is optimized for accuracy and reliability in challenging conditions such as low-perfusion or thick-tissue environments, ensuring dependable monitoring of arterial oxygen saturation (SpO₂) in both neonatal and adult patients. This makes it particularly suitable for patients where traditional sensors may struggle to provide consistent readings.
Is the Nellcor OxySoft Neonatal-Adult SpO₂ Sensor reusable, and what are the storage requirements to maintain its performance?
The Nellcor OxySoft Neonatal-Adult SpO₂ Sensor is a single-use, disposable device, meaning it is intended for one-time use only. To maintain its integrity and performance, storage must strictly follow the manufacturer’s guidelines—details of which are provided in the accompanying documentation. Improper storage could compromise sensor accuracy or functionality, so adherence to these instructions is critical for reliable clinical use.
Can this sensor be used with any pulse oximeter, or does it require compatibility with specific devices?
The Nellcor OxySoft Neonatal-Adult SpO₂ Sensor is designed for use only with compatible pulse oximeters, as specified by the manufacturer. While it is not explicitly restricted to a single brand, it must be paired with devices that support its OxySoft technology to ensure accurate and reliable SpO₂ readings. Always verify compatibility with your existing oximetry equipment before use.
What safety precautions should be taken when handling the Nellcor OxySoft Neonatal-Adult SpO₂ Sensor, particularly regarding its use in high-risk environments?
The sensor must be handled according to the manufacturer’s guidelines to ensure proper function and patient safety. Notably, it is not intended for MRI use, as exposure to magnetic fields could compromise its performance or pose risks. Additionally, adherence to sterile handling practices is recommended in clinical settings like NICU or critical care, where infection control is paramount. Always follow the provided instructions to avoid potential hazards.
How does the regulatory pathway for this device differ from other pulse oximetry sensors, and what does the product code DQA indicate?
This device follows the FDA 510(k) clearance pathway, specifically under the Traditional route with a decision code of SESE (Substantially Equivalent). The product code DQA categorizes it under the Cardiovascular panel (AN) for review purposes, indicating its classification as a diagnostic device related to blood oxygen monitoring. This route ensures compliance with U.S. regulatory standards for non-invasive pulse oximetry sensors, though the exact implications for clinical use are determined by the manufacturer’s intended purpose.
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: Nellcor™ OxySoft™ SpO₂ sensor - Medtronic, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft ..., OXYSOFTN | Medtronic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212555 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien llc
- FDA Applicant
- Covidien, LLC
Sources (1)
- FDA 510(k) K212555 24 fields · synced Sep 20, 2026