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philips avalon fetal monitor models fm20 and fm30
Philips Medizin Systeme Boeblingen
Summary: The Philips Avalon fetal monitor models FM20 and FM30 are used for continuous monitoring of fetal heart rate and uterine activity. Cleared by the FDA, these devices are primarily used in obstetric care settings. Key evidence highlights the development of smart modules for remote monitoring.
FDA Clearance Information
Pathway
510K
Number
K052795 ↗
Decision Date
December 30, 2005
Product Code
HGM
Device Class
Class 2
Evidence
419 studies
The Philips Avalon fetal monitor models FM20 and FM30 were cleared through the FDA 510(k) pathway on December 30, 2005. Manufactured by Philips Medizin Systeme Boeblingen, these devices are classified as Class 2 under product code HGM.
What It Is
The Philips Avalon fetal monitor models FM20 and FM30 are medical devices designed for continuous monitoring of fetal heart rate and uterine activity during pregnancy and labor. They provide clinicians with real-time data to assess fetal well-being and maternal uterine contractions.
Clinical Applications
These fetal monitors are commonly used in hospital labor and delivery units to monitor fetal and maternal health during childbirth. They are also utilized in high-risk pregnancies to ensure timely interventions if fetal distress is detected.
Evidence Summary
The available literature includes four studies, with types ranging from randomized controlled trials to prospective and retrospective analyses. The studies span from 2018 to 2024, focusing on the development and application of fetal monitoring technologies.
Reported Outcomes
Published studies report advancements in fetal monitoring technology, including the development of smart mobile data modules for remote monitoring. These innovations aim to enhance the accessibility and accuracy of fetal heart rate monitoring in various settings.
Safety Profile
Reported complications include potential inaccuracies in fetal heart rate readings due to device malfunctions or improper sensor placement. However, specific adverse events related to the use of these devices were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of detailed safety data and specific outcome measures. Further research is needed to evaluate the long-term efficacy and safety of these devices in diverse clinical settings.
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
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 are the clinical indications for Philips Avalon fetal monitor models FM20 and FM30?
These devices are indicated for continuous monitoring of fetal heart rate and uterine activity during pregnancy and labor.
What outcomes have been reported in clinical studies?
Studies have reported advancements in remote monitoring technology, improving the accessibility and accuracy of fetal heart rate monitoring.
What complications have been reported?
Reported complications include potential inaccuracies in readings due to device malfunctions or improper sensor placement.
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.