📋 FDA Reference
Philips Avalon Fetal Monitors FM20 FM30 FM40 and FM50
Philips Medizin Systeme Boeblingen
Summary: The Philips Avalon Fetal Monitors (FM20, FM30, FM40, FM50) are used for monitoring fetal and maternal parameters during pregnancy and labor. They are primarily used by obstetricians and midwives in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K092028 ↗
Decision Date ?
February 17, 2010
Product Code ?
HGM
Device Class ?
Class 2
Evidence ?
419 studies
The Philips Avalon Fetal Monitors were cleared via the FDA 510k pathway on February 17, 2010. Manufactured by Philips Medizin Systeme Boeblingen, these devices are classified as Class 2 under product code HGM.
What It Is
The Philips Avalon Fetal Monitors are advanced medical devices designed to track fetal heart rate, uterine contractions, and maternal vital signs. They use non-invasive techniques such as ultrasound and tocodynamometry to provide continuous monitoring, ensuring the safety and well-being of both mother and fetus during labor and delivery.
FDA-Cleared Indications
- Monitoring fetal heart rate during pregnancy and labor.
- Monitoring uterine activity, including contractions, during pregnancy and labor.
- Monitoring selected maternal physiological parameters during pregnancy and labor.
Clinical Applications
- Antepartum fetal monitoring in an obstetric care setting.
- Intrapartum monitoring during labor and delivery.
- Assessment of fetal heart-rate patterns and uterine activity.
- Monitoring maternal and fetal status when continuous observation is clinically indicated.
Practical Considerations
- The FM20, FM30, FM40, and FM50 are configured for different combinations of fetal and maternal monitoring functions; compatible transducers and accessories should be verified for the specific model.
- External monitoring commonly uses an ultrasound transducer for fetal heart rate and a tocodynamometer for uterine activity; signal quality can be affected by fetal position, maternal movement, body habitus, and transducer placement.
- The monitor is generally used at the bedside in labor and delivery or antepartum units and may connect with approved clinical information systems or central monitoring stations.
- This is an electronic monitoring system, not an implantable device or an MRI scanner accessory. Follow the model-specific labeling and hospital policy before use near MRI equipment.
- Monitoring results require interpretation by qualified obstetric clinicians and should be considered with the overall maternal and fetal clinical assessment.
Related Literature
The linked study investigated the impact of noise levels from nonstress test devices on stress parameters in first-time pregnant women. Although the abstract is not available, such studies typically focus on how device noise might affect patient comfort and stress levels. Limitations may include a small sample size or lack of detailed outcome measures.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
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Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
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Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
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Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
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Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
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Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
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Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
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Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
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pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
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Comparative connectomics of Drosophila descending and ascending neurons.
Nature
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Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Philips Avalon Fetal Monitors used for?
They are used for monitoring fetal heart rate, uterine contractions, and maternal vital signs during pregnancy and labor.
What specialties typically use this device?
Obstetrics and midwifery specialties commonly use these monitors in hospital labor and delivery settings.
What are the FDA-cleared indications?
The monitors are indicated for tracking fetal and maternal conditions during pregnancy and labor, focusing on fetal heart rate and uterine activity.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.