Intellivue Cl Spo2 Pod And Cl Nbp Pod, Philips Intellivue Patient Monitors Mp5,…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131913 FDA 510(k)
- FDA Product Code
- DRG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2910 FDA 510(k)
- Regulation Number
- 870.2910 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IntelliVue CL SpO₂ Pod and CL NBP Pod are wireless physiological signal transmitters designed for non-invasive monitoring of oxygen saturation (SpO₂) and non-invasive blood pressure (NBP). These devices fall under the category of transmitters and receivers for physiological signals, enabling continuous wireless data transmission to compatible patient monitors like the MP5, MP5T, and MP5SC series.
These cableless pods are intended for use in clinical settings such as hospitals, where they connect wirelessly to the IntelliVue patient monitoring systems. They are reusable, non-sterile devices and are compatible with MRI environments, though specific safety guidelines must be followed. Supplied as part of the IntelliVue Cableless Measurements system, they require pairing with the MP5 series monitors and are regulated under FDA 510(k) and MDD standards. Each pod is designed for single-patient use in sequential sessions, adhering to standard hospital infection control protocols.
Frequently asked questions
Are the IntelliVue CL SpO₂ and CL NBP Pods designed for single-use or reuse in clinical settings?
The IntelliVue CL SpO₂ and CL NBP Pods are reusable devices, but they are intended for single-patient use in sequential sessions to adhere to standard hospital infection control protocols. This means they can be reused across different patients as long as proper cleaning and disinfection procedures are followed between uses.
How do these pods connect to the IntelliVue patient monitors, and what monitors are compatible with them?
The IntelliVue CL SpO₂ and CL NBP Pods are wireless transmitters that connect to compatible IntelliVue patient monitors via radiofrequency signals. They are specifically designed to pair with the MP5, MP5T, and MP5SC series monitors, enabling continuous wireless monitoring of oxygen saturation (SpO₂) and non-invasive blood pressure (NBP).
Can these pods be used in an MRI environment, and if so, are there any special considerations?
Yes, the IntelliVue CL SpO₂ and CL NBP Pods are compatible with MRI environments, but their use requires adherence to specific safety guidelines to ensure proper operation and patient safety. Always follow manufacturer-recommended protocols when using wireless devices near MRI machinery.
Are the IntelliVue CL SpO₂ and CL NBP Pods sterile, and if not, how should they be handled to maintain hygiene?
The pods are non-sterile devices. Since they are reusable, they must be properly cleaned and disinfected between uses to maintain hygiene and prevent cross-contamination. Follow your facility’s infection control protocols for reprocessing reusable medical devices.
What regulatory pathways have these pods undergone, and what does that mean for their use in clinical settings?
The IntelliVue CL SpO₂ and CL NBP Pods have been cleared under FDA 510(k) and MDD (Medical Device Directive) regulatory pathways. This means they have been evaluated for safety and performance by regulatory authorities and are considered substantially equivalent to previously cleared devices in their category. Their clearance does not define clinical indications but confirms compliance with regulatory standards for use in monitoring physiological signals.
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: Philips CL SpO2 Pod, CL NBP Pod, CL Respiration Pod IntelliVue ..., PDF Philips IntelliVue Cableless Measurements Technical Data Sheet.pdf, Intellivue Cl Spo2 Pod and Cl Nbp Pod, Philips Intellivue Patient ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K131913 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Boeblingen GmbH
Sources (2)
- FDA 510(k) K131913 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026