Avalon CL Fetal & Maternal Pod (866488), Avalon CL Fetal & Maternal Patch (989803196341)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233440 FDA 510(k)
- FDA Product Code
- HGM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2740 FDA 510(k)
- Regulation Number
- 884.2740 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Avalon CL Fetal & Maternal Pod and Patch is a system for non-invasive perinatal monitoring, designed to track fetal and maternal physiological parameters during pregnancy and labor. It combines adhesive patches and a wireless pod to enable continuous, wireless data transmission for real-time assessment of fetal heart rate and maternal contractions without the constraints of traditional belt-based systems.
This device is intended for use in clinical obstetrics settings and is supplied as a reusable pod paired with single-use adhesive patches. The system adheres to FDA 510(k) and MDD regulatory standards, with no specific MRI safety restrictions noted. The patches are applied directly to the maternal abdomen, while the pod communicates wirelessly with monitoring equipment, ensuring mobility and comfort for the patient. Authorisations include FDA clearance under K233440 and compliance with the Medical Device Directive (MDD).
Frequently asked questions
How is the Avalon CL Fetal & Maternal system different from traditional belt-based fetal monitoring systems in terms of patient comfort and mobility?
The Avalon CL Fetal & Maternal system replaces traditional belt-based monitors with adhesive patches and a wireless pod, eliminating the need for restrictive straps around the abdomen. This design enhances patient comfort by reducing pressure and irritation while allowing greater mobility during pregnancy and labor, as the wireless pod communicates data without physical tethering.
Are the adhesive patches for the Avalon CL Fetal & Maternal system reusable or single-use, and how does this affect clinical workflow?
The adhesive patches for the Avalon CL Fetal & Maternal system are designed for single-use, ensuring hygiene and reducing the risk of cross-contamination between patients. This simplifies clinical workflow by eliminating the need for cleaning or reprocessing between uses, as each patient receives a fresh patch application.
What regulatory pathways does the Avalon CL Fetal & Maternal system follow, and how does this impact its use in clinical settings?
The Avalon CL Fetal & Maternal system is cleared under the FDA’s 510(k) pathway (K233440) and complies with the Medical Device Directive (MDD), confirming its safety and performance for obstetric monitoring. This regulatory clearance ensures it meets established standards for perinatal monitoring, allowing clinicians to rely on its accuracy for fetal heart rate and maternal contraction tracking in clinical settings.
Can the Avalon CL Fetal & Maternal Pod be used with MRI equipment, and if not, what precautions should be taken?
The device data does not specify any MRI safety restrictions for the Avalon CL Fetal & Maternal Pod, but it is always recommended to verify compatibility with your facility’s MRI protocols. Since wireless communication is used, there may be no direct electromagnetic interference, but standard MRI safety guidelines—such as removing or securing non-MRI-safe devices—should still be followed to avoid potential risks.
What types of clinical settings is the Avalon CL Fetal & Maternal system intended for, and what makes it suitable for those environments?
The system is explicitly designed for clinical obstetrics settings, including labor and delivery units, where continuous monitoring of fetal heart rate and maternal contractions is critical. Its wireless, patch-based design reduces patient discomfort and allows for unobstructed movement, making it ideal for active labor scenarios where mobility and ease of use are essential.
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 - Avalon beltless fetal monitoring solution - Philips, Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal ..., Avalon beltless fetal monitoring | Philips - Philips
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 | K233440 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Boeblingen GmbH
Sources (2)
- FDA 510(k) K233440 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026