Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flex…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162014 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 Flexible SpO₂ Sensor, Small, is a reusable pulse oximetry sensor designed for non-invasive monitoring of peripheral oxygen saturation (SpO₂). It adheres to the definition of a pulse oximeter sensor (FDA Product Code: DQA), providing continuous, real-time blood oxygen level measurements via photoplethysmography. The flexible design accommodates a range of patient sizes, including those weighing over 20 kg, ensuring adaptability for clinical and home-use applications. Its compact dimensions (22 x 36 mm) and modular connector facilitate compatibility with compatible pulse oximeters, including Nellcor Oximax systems.
This reusable sensor is intended for short-term, intermittent use in controlled environments such as hospitals, transport, home care, and extreme settings. It is not sterile and requires cleaning via dipping to maintain hygiene between uses, as specified in its design. The device holds FDA 510(k) clearance (K162014) under the Cardiovascular Advisory Committee, with no MRI safety restrictions noted. Storage instructions are not detailed in the data, but standard medical device hygiene protocols should apply. The sensor is supplied with a connector and housing, adhering to regulatory requirements for reusable monitoring devices.
Frequently asked questions
What is the Nellcor Flexible SpO₂ Sensor, Small used for?
The Nellcor Flexible SpO₂ Sensor, Small is designed for non-invasive, continuous monitoring of peripheral oxygen saturation (SpO₂) in patients. It uses photoplethysmography to measure blood oxygen levels in real-time, making it suitable for short-term, intermittent use in environments like hospitals, transport, home care, and extreme settings. Its flexible design ensures adaptability for a range of patient sizes, including those weighing over 20 kg.
Is the Nellcor Flexible SpO₂ Sensor, Small reusable or single-use?
The Nellcor Flexible SpO₂ Sensor, Small is a reusable device. It is intended for short-term, intermittent use between cleaning cycles. After each use, it must be cleaned by dipping to maintain hygiene, as specified in its design. This reusable nature aligns with regulatory requirements for monitoring devices used in controlled environments.
What are the dimensions and compatibility of the Nellcor Flexible SpO₂ Sensor, Small?
The sensor has compact dimensions of 22 x 36 mm, allowing for easy placement on various body parts. It features a modular connector designed for compatibility with compatible pulse oximeters, including Nellcor Oximax systems. This modularity ensures flexibility in clinical and home-use applications while maintaining reliable performance.
How should the Nellcor Flexible SpO₂ Sensor, Small be stored?
While specific storage instructions are not detailed in the provided data, standard medical device hygiene protocols should be followed. This includes keeping the sensor clean, dry, and protected from contamination or physical damage. Proper storage ensures the sensor remains functional and hygienic for subsequent uses.
Does the Nellcor Flexible SpO₂ Sensor, Small have any MRI safety restrictions?
The Nellcor Flexible SpO₂ Sensor, Small does not have any noted MRI safety restrictions in the available documentation. However, it is important to follow standard safety protocols when using any medical device near MRI equipment, as conditions can vary based on specific clinical settings and equipment configurations.
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™ flexible reusable SpO₂ sensor - Medtronic, MEDTRONIC NELLCOR Flexible SPO2 Sensor - amazon.com, Nellcor™ Flexible SpO₂ Reusable Sensor | Medtronic (NZ), Nellcor™ Flexible SpO2 Sensors - Bound Tree
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162014 | Class II | Active |
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Manufacturer
- Manufacturer
- BluePoint Medical GmbH & Co. KG
Sources (1)
- FDA 510(k) K162014 24 fields · synced Oct 5, 2026