Avalon Fetal Monitor Models FM20 and FM30
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K052795 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 Fetal Monitor Models FM20 and FM30 are classified as Systems, Monitoring, Perinatal and designed for continuous fetal heart rate monitoring during pregnancy and labor. These devices provide real-time assessment of fetal and maternal heart rates, incorporating automated coincidence detection (cross-channel verification) to enhance diagnostic accuracy by distinguishing between maternal and fetal signals.
Supplied as reusable medical devices, the FM20 and FM30 are intended for use in obstetric settings, including antepartum visits, labor, delivery, postpartum care, and newborn nursery monitoring. They connect to Philips obstetrical information management systems (e.g., IntelliSpace Perinatal or OB TraceVue) for integrated data tracking. Regulated under the FDA 510(k) pathway with a Special Review classification and classified as Class II devices, these monitors comply with the EU Medical Device Directive (MDD) and are authorized under regulation number 884.2740.
Frequently asked questions
Are the Philips Avalon Fetal Monitor FM20 and FM30 designed for single-use or reusable in clinical settings? Why does this matter?
The Philips Avalon Fetal Monitor FM20 and FM30 are reusable medical devices, as explicitly stated in the device description. This matters because reusable devices require proper cleaning, disinfection, and maintenance protocols to ensure patient safety and device reliability across multiple uses. Unlike single-use devices, these monitors must be serviced according to manufacturer guidelines to maintain accuracy and functionality over time.
What types of obstetric settings can the FM20 and FM30 be used in, and how do they integrate with other systems?
The FM20 and FM30 are designed for obstetric settings across all phases of maternal and neonatal care, including antepartum visits, labor, delivery, postpartum care, and newborn nursery monitoring. They connect to Philips obstetrical information management systems like IntelliSpace Perinatal or OB TraceVue for seamless data tracking and integration, enabling comprehensive fetal and maternal heart rate monitoring with automated verification.
What regulatory pathways have the FM20 and FM30 followed, and what does this mean for their use in the U.S. and EU?
The FM20 and FM30 were cleared via the FDA 510(k) pathway with a Special Review classification and are classified as Class II devices. In the EU, they comply with the EU Medical Device Directive (MDD) under regulation number 884.2740. This means they meet stringent safety and performance standards for both markets, ensuring authorized use in obstetric monitoring while adhering to local regulatory requirements.
How does the automated coincidence detection feature improve the accuracy of fetal heart rate monitoring?
The FM20 and FM30 incorporate automated coincidence detection (cross-channel verification), which enhances diagnostic accuracy by distinguishing between maternal and fetal heart signals. This feature reduces false readings by cross-referencing signals from multiple channels, minimizing errors that could occur from overlapping or ambiguous heartbeats during monitoring.
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 FM30 Fetal monitor - Philips, Philips - Avalon FM20 Fetal monitor - Philips, PDF Avalon FM20 and FM30 - 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 | K052795 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Boeblingen GmbH
Sources (2)
- FDA 510(k) K052795 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026