Rainbow Adhesive Co-Oximetry Sensors
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063140 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 Rainbow Adhesive Co-Oximetry Sensors are adhesive pulse oximetry sensors designed for non-invasive monitoring of oxygenation and advanced blood parameters. These sensors incorporate co-oximetry technology to measure multiple hemoglobin fractions, including total hemoglobin (SpHb) and methemoglobin (SpMet), alongside traditional pulse oximetry readings such as SpO₂ and perfusion index.
These sensors are intended for single-use applications in clinical settings, including hospitals, intensive care units, and operating rooms. Supplied sterile and packaged individually, they adhere to the skin for continuous monitoring and are compatible with Masimo’s rainbow Pulse CO-Oximetry platform. The device holds FDA 510(k) clearance under K063140, classified under product code DQA, and is intended for use with Masimo’s monitoring systems as specified in the regulatory submission.
Frequently asked questions
Are these sensors reusable or meant for single-use, and how should they be handled after use?
The Rainbow Adhesive Co-Oximetry Sensors are explicitly designed for single-use only in clinical settings like hospitals, ICUs, and operating rooms. Since they are supplied sterile and packaged individually, they should not be reused or reprocessed. After use, they must be discarded according to standard biohazard waste protocols to ensure patient safety and prevent cross-contamination.
What advanced blood parameters do these sensors measure beyond traditional pulse oximetry?
Beyond standard SpO₂ (oxygen saturation) and perfusion index readings, these sensors use co-oximetry technology to measure total hemoglobin (SpHb) and methemoglobin (SpMet) levels. This allows for more detailed monitoring of hemoglobin fractions, which can be critical in assessing patient oxygenation and potential metabolic issues in clinical environments.
How are these sensors packaged and stored, and what compatibility considerations should clinicians keep in mind?
The sensors are supplied sterile and individually packaged, ensuring readiness for immediate use in sterile clinical settings. They are designed to adhere to the skin for continuous monitoring and are compatible exclusively with Masimo’s Rainbow Pulse CO-Oximetry platform. Clinicians should store them in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and functionality until use.
What types of clinical environments are these sensors intended for, and why?
These sensors are intended for use in high-acuity clinical environments such as hospitals, intensive care units (ICUs), and operating rooms. Their advanced co-oximetry capabilities and continuous monitoring functionality make them particularly useful in settings where precise hemoglobin and oxygenation data are critical for patient management, such as during surgeries or in critically ill patients.
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: Masimo - Sensors and Cannulas, Masimo - rainbow® Pulse CO-Oximetry, Masimo - rainbow Sensors
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063140 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA 510(k) K063140 24 fields · synced Sep 19, 2026