đź“‹ FDA Reference

philips avalon fetal monitors fm20 and fm30

Philips Medizinsysteme Boeblingen Gmbh, Cardiac An

Summary: The Philips Avalon FM20 and FM30 are fetal monitors used to track fetal and maternal vital signs during pregnancy. They are primarily used by obstetricians and healthcare professionals in maternity wards.

FDA Clearance Information

Pathway 510K
Decision Date September 27, 2007
Product Code HGM
Device Class Class 2
Evidence 419 studies

The Philips Avalon fetal monitors FM20 and FM30 were cleared through the FDA 510k pathway on September 27, 2007. Manufactured by Philips Medizinsysteme Boeblingen Gmbh, these devices are classified as Class 2 under product code HGM.

What It Is

The Philips Avalon FM20 and FM30 are advanced fetal monitoring systems designed to measure and track fetal heart rate, maternal uterine activity, and other vital signs during pregnancy. These monitors use non-invasive sensors to provide continuous monitoring, ensuring the well-being of both mother and fetus. They are equipped with features that allow for real-time data analysis and integration into hospital information systems.

Clinical Applications

These fetal monitors are commonly used in obstetric settings, such as maternity wards and labor and delivery units, to ensure the health and safety of the fetus and mother during pregnancy and childbirth. They are particularly useful in high-risk pregnancies where continuous monitoring is essential. The devices are used by obstetricians, midwives, and nurses to monitor fetal and maternal parameters, aiding in timely clinical decision-making.

Indications for Use

The FDA indications suggest that these devices are intended for monitoring fetal and maternal vital signs during pregnancy. They are particularly useful in scenarios where continuous observation is needed to ensure the health of the mother and fetus.

Practical Considerations

The Philips Avalon monitors are compatible with a range of sensors and accessories, allowing for flexible use in various clinical settings. They are designed to be user-friendly, with intuitive interfaces that facilitate quick setup and operation. Clinicians should ensure proper sensor placement for accurate readings.

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 aim to understand how device noise may affect patient comfort and stress levels. Limitations might include a small sample size or lack of detailed methodology, which could affect the generalizability of findings.

Linked Studies (20)

PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

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

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical progress note: Haemophilus influenzae type b.

Journal of hospital medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Pilot study of social media promotion of home-based self-testing for syphilis.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

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

View Source →
PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

View Source →
PubMed • 2025

Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.

The Journal of clinical investigation

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.

Hellenic journal of nuclear medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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

RCT View Source →
PubMed • 2025

pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.

Magnetic resonance in medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Comparative connectomics of Drosophila descending and ascending neurons.

Nature

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

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 FM20 and FM30 used for?

These monitors are used for tracking fetal heart rate and maternal uterine activity during pregnancy.

What specialties typically use this device?

Obstetricians, midwives, and nurses in maternity wards and labor and delivery units.

What are the FDA-cleared indications?

The devices are indicated for monitoring fetal and maternal vital signs during pregnancy.

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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.