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hydrophilic silicone foley catheter and personal catheter hydrophilic and non-hydrophilic
Rochester Medical
Summary: The hydrophilic silicone Foley catheter by Rochester Medical is designed for urinary catheterization. It is FDA 510k cleared and supported by studies focusing on antimicrobial properties and patient comfort.
FDA Clearance Information
Pathway
510K
Number
K000723 ↗
Decision Date
May 19, 2000
Product Code
KOD
Device Class
Class 2
Evidence
419 studies
The hydrophilic silicone Foley catheter by Rochester Medical was cleared through the FDA 510k pathway on May 19, 2000. It is classified as a Class 2 device under product code KOD.
What It Is
The hydrophilic silicone Foley catheter is a urinary catheter designed to facilitate bladder drainage. It features a hydrophilic coating that reduces friction during insertion, improving patient comfort and reducing the risk of urethral trauma.
Clinical Applications
This device is commonly used in clinical settings for patients requiring bladder drainage, particularly in cases where reduced friction is beneficial, such as in patients with sensitive urethras or those prone to catheter-associated discomfort.
Evidence Summary
The available literature includes randomized controlled trials and reviews, with a total of 5 studies ranging from 1986 to 2025. These studies explore antimicrobial coatings, patient comfort, and procedural efficiency.
Reported Outcomes
Published studies report improved patient comfort and procedural efficiency with hydrophilic coatings compared to conventional silicone catheters. Antimicrobial coatings have shown potential in reducing bacterial colonization, enhancing the catheter's safety profile.
Safety Profile
Reported complications include potential urethral trauma and discomfort, although hydrophilic coatings may mitigate these risks. No significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale, long-term studies. Further research is needed to confirm the long-term benefits and safety of hydrophilic coatings in diverse patient populations.
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 hydrophilic silicone Foley catheters?
Indicated for urinary catheterization in patients requiring bladder drainage, particularly where reduced friction is beneficial.
What outcomes have been reported in clinical studies?
Studies report improved patient comfort and reduced bacterial colonization with hydrophilic coatings.
What complications have been reported?
Reported complications include potential urethral trauma and discomfort, though hydrophilic coatings may reduce these risks.
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.